Category: Device Advisories

FDA Advisory No. 2020-2184-A || Lifting the Advisory of the Products under FDA Advisory No. 2020-2184 entitled Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products: 1. Hisamitsu® Bye-Bye Fever (For Adults) 2. Hisamitsu® Bye-Bye Fever (For Babies)

The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device products mentioned above has Certificate of Exemption (CoE) issued to Hisamitsu Pharmaceutical Co., Inc., Marketing Authorization Holder. Based on FDA Circular No. 2020-001 all Certificate of Exemption for Class A medical devices issued from 25 February 2014 shall remain valid until 03 November 2021 or within 2 years from date of effectivity of this Circular whichever is earlier.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-2184 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unnotified medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there befindings of any violation of the company to the existing laws, rules and regulations

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-2184-A

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2184-A || Lifting the Advisory of the Products under FDA Advisory No. 2020-2184 entitled Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products: 1. Hisamitsu® Bye-Bye Fever (For Adults) 2. Hisamitsu® Bye-Bye Fever (For Babies)

FDA Advisory No. 2021-0104 || Public Health Warning Against the Purchase and Use of Uncertified COVID-19 Test Kits intended for Self-Administration

The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that to date, there is no FDA Certified COVID-19 Test Kits for Self-Administration.

In light of the foregoing, all healthcare professionals and the general public are advised not to purchase and use these in-vitro devices.

All concerned establishments are warned not to distribute, advertise, or sell the said Uncertified medical device until FDA Special Certification is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this uncertified product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.                                                                                         

To report any sale or distribution of unauthorized medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0104

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0104 || Public Health Warning Against the Purchase and Use of Uncertified COVID-19 Test Kits intended for Self-Administration

FDA has released a total of 358 COVID – 19 Test Kits (123 – PCR based, 106 – Rapid Antibody, 68 – Immunoassay and 61 – Others).

As of 21 January 2021, FDA has released a total of 358 COVID – 19 Test Kits (123 – PCR based, 106 – Rapid Antibody, 68 – Immunoassay and 61 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2021-0035 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “ZHAD YANG MEDICAL COTTON SWABS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx, MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0035

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0035 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “ZHAD YANG MEDICAL COTTON SWABS”

FDA Advisory No. 2021-0034 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “DISPOSABLE FACE MASK 99% BACTERIA FILTRATION EFFICIENCY”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                          

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0034

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0034 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “DISPOSABLE FACE MASK 99% BACTERIA FILTRATION EFFICIENCY”

FDA Advisory No.2021-0011 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “AIDELAI™ DISPOSABLE FACE MASK”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                        

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0011

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0011 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “AIDELAI™ DISPOSABLE FACE MASK”

FDA Advisory No.2021-0010 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “DISPOSABLE MEDICAL MASK”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0010

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0010 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “DISPOSABLE MEDICAL MASK”

FDA Advisory No. 2020-2218 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “DIGITAL THERMOMETER 1.0oC”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

1.DIGITAL THERMOMETER 1.0°C

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                          

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2218

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2218 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “DIGITAL THERMOMETER 1.0oC”

FDA Advisory No. 2020-2217 || Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

1. JUST MASK – ANTI-VIRAL FACE MASK
2. HEALTH MASTER – DISPOSABLE PROTECTIVE MASK

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not notified and no corresponding Product Notification Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unnotified medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Notification Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unnotified products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2217

FDA Advisory No. 2020-2185 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “CHERUB DAILY PROTECTIVE MASK”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

1. CHERUB DAILY PROTECTIVE MASK

The FDA verified through post-marketing surveillance that the abovementioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                      

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2185

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2185 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “CHERUB DAILY PROTECTIVE MASK”

FDA Advisory No. 2020-2184 || Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

1. HISAMITSU® BYE-BYE FEVER (FOR ADULTS)
2. HISAMITSU® BYE-BYE FEVER (FOR BABIES)

The FDA verified through post-marketing surveillance that the abovementioned medical device products are not notified and no corresponding Product Notification Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unnotified medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unnotified products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                       

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2184

FDA Advisory No. 2020-2183 || Delisted Companies with Issued Special Certification for COVID-19 Test Kits

The Food and Drug Administrative (FDA) informs all concerned stakeholders and the general public that the following companies with issued Special Certification for COVID-19 Test Kits have voluntarily surrendered their authorization to market the product:

Company’s Name Product Name SC Control Number Classification
 

1.

MDX

Netherlands Diagnostics, Inc.

FOSUN COVID-19 RT-PCR DETECTION KIT SC-COVID19- 2020-183  

PCR

 

2.

MDX

Netherlands Diagnostics, Inc.

Real-Time Flourescent RT-PCR Kit for Detecting SARS-2019 nCoV SC-COVID19- 2020-148  

PCR

 

3.

Clearbridge Medical

Philippine

NANJING VAZYME 2019- nCoV IgG/IgM DETECTION

KIT

SC-COVID19- 2020-029  

RAPID

4. UC Biosciences Inc. ORIGHT COVID-19 IgG/IgM RAPID TEST KIT SC-COVID19- 2020-250 RAPID
5. UC Biosciences Inc. Cellex Qsars-CoV-2 IgG/IgM Cassette Rapid Test SC-COVID19- 2020-104 RAPID
6. UC Biosciences

Inc.

2019-nCoV-2 ANTIBODY

TEST (COLLOIDAL GOLD)

SC-COVID19-

2020-102

RAPID
 

7.

Biopharma Medical Solutions, Inc. SARS-CoV-2 FLOURESCENT PCR SC-COVID19- 2020-079  

PCR

 

8.

Biopharma

Medical Solutions, Inc.

SOLGENT DiaPlexQ™

NOVEL CORONAVIRUS (2019-nCoV) DETECTION KIT

SC-COVID19- 2020-090  

PCR

 

9.

Clearbridge

Medical Philippines, Inc.

SAVANT™ New Coronavirus (SARS-CoV-2) N Protein SC-COVID19- 2020-657  

RAPID

 

10.

 

Indoplas Philippines, Inc.

SARS-CoV-2 Antibody Test (Lateral Flow Method) – Guangzhou Wondfo Biotech Co., Ltd.  

SC-COVID19- 2020-091

 

RAPID

 

11.

Crestline Scientific Corporation Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test SC-COVID19- 2020-161  

RAPID

 

12.

Murex Diagnostic Products Specialists  

SARS-CoV-2 Flourescent PCR

 

SC-COVID19- 2020-182

 

PCR

 

 

13.

Adamson Medtex International Corp. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-

2) (COLLOIDAL GOLD) – Zhuhau Livzon Diagnostic Inc.

 

SC-COVID19- 2020-032

 

 

RAPID

 

14.

Aglobal Care Inc. 2019-nCoV ANTIBODY TEST

(COLLOIDAL GOLD) – INNOVITA

SC-COVID19- 2020-099  

RAPID

15. St. Tyke, Inc. PCL COVID19 IgG/IgM RAPID GOLD SC-COVID19- 2020-396 RAPID

For more information and inquiries, kindly contact the FDA-Center for Device Regulation, Radiation Health, and Research through email address at [email protected] or call (02) 8857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2183

FDA Advisory No. 2020-1691-A || Lifting of the FDA Advisory No. 2020 – 1691 entitled: Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the following medical device products have been registered by the Market Authorization Holder, OMM Healthcare Philippines Corporation, in accordance to existing FDA rules and regulations:

1. NIPRO SYNTHETIC HOLLOW FIBER DIALYZER ELISIO™ 190HR
2. NIPRO ELISIO™ – 17H SYNTHETIC HOLLOW FIBER POLYNEPHRON

Accordingly, the warning against the purchase and use of the subject medical device products as mentioned in FDA Advisory No. 2020-1691 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1691-A

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1691-A || Lifting of the FDA Advisory No. 2020 – 1691 entitled: Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

FDA Advisory No. 2020-2128 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

1. SYRINGE 20 mL IN FOREIGN CHARACTERS
2. SYRINGE 20 mL IN FOREIGN CHARACTERS

The FDA verified through post-marketing surveillance that the above-mentioned medical device products are not registered and no corresponding Product Registration Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Registration Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2128

FDA Advisory No. 2020-157-A || Termination of the Voluntary Recall of Unisepta® Foam 2 Medical Device Disinfectant 750ml as Stated in the FDA Advisory No. 2020-157

This is to inform the public and concerned healthcare professionals that the Voluntary recall order issued on specific lots of Unisepta® Foam 2 Medical Device Disinfectant 750ml as shown in the table below is hereby terminated by the Food and Drug Administration (FDA).

Product Name Lot Number
Unisepta® Foam 2 Medical Device Disinfectant 750ml A08702S
A21511S
A31010S
B10630S

As stated in the FDA Advisory No. 2020-157 dated 13 February 2020, Dental Domain has conducted the voluntary recall of the aforementioned product due to the announcement from their supplier, USF Healthcare. According to their supplier, a contamination with gram negative bacteria found in water has been identified in the manufacturing process of the affected products at their subcontractor. The bacteria pose little medical risk to healthy people. However, immunocompromised patients are at higher risk of infection. They have moved to test their products to ensure the safety and decontamination of the manufacturing facilities has been done.

After due and thorough evaluation of the submitted documents by Dental Domain, FDA has determined that reasonable efforts have been made to recall and properly destroy the affected product lots in accordance with FDA Circular No. 2016-012, known as the Guidelines on Product Recall.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be subsequent findings of any violation of existing FDA laws, rules and regulations.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to monitor and seize the cited product lots if still found available in the market.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 local 8301.

Dissemination of this advisory to all concerned is hereby requested

Attachment:-> FDA-Advisory-No.2020-157-A

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-157-A || Termination of the Voluntary Recall of Unisepta® Foam 2 Medical Device Disinfectant 750ml as Stated in the FDA Advisory No. 2020-157

FDA Advisory No. 2020-2093 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ALIEN CONDOM”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                          

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2093

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2093 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ALIEN CONDOM”

FDA Advisory No. 2020-2092 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “LLC RAPID TEST KIT FOR SARS-COV-2 (COVID19)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified Covid-19 test kit:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not certified and no corresponding Special Certification has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this uncertified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the FDA Special Certification is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been certified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this uncertified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered/uncertified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2092

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2092 || Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “LLC RAPID TEST KIT FOR SARS-COV-2 (COVID19)”

FDA Advisory No. 2020-2075 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “DIGITAL THERMOMETER WITH BEEPER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Read more:-> FDA-Advisory-No.2020-2075

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FDA Advisory No. 2020-2022 || REITERATION OF THE MANDATORY LABELING REQUIREMENTS FOR TOYS AND CHILD CARE ARTICLE PRODUCTS PURSUANT TO THE IRR OF RA 10620

Pursuant to the Implementing Rules and Regulation of Republic Act 10620, otherwise known as “Toy and Game Safety Labeling Act of 2013”, Toy and Game refers to an object or a number of objects clearly intended as plaything for children below fourteen (14) years of age.

Toys and Game including Childcare Articles are favorite items for gift-giving during special occasions such as birthdays, parties and Christmases.

The Food and Drug Administration (FDA) having the mandate to issue appropriate authorizations to establishments and their toy and game products reiterates the mandatory labeling requirement for Toys and Child Care Article (TCCA) products. The following information shall appear on the package, container, wrapper or protective covering of the products: (See attached infographics for easy reference)

  1. License to Operate (LTO) Number issued by FDA
  2. Age Grading
  3. Cautionary Statement/Warnings
  4. Instructional Literature
  5. Manufacturer’s markings with complete name and address of the local company
  6. Item Model / Stock Keeping Unit (SKU) number

The label shall be generally written in English, otherwise, a parallel translation in English or Filipino or both shall appear thereon. The label shall be in a visible, easily legible, understandable and indelible form.

Thus, consumers are advised to be vigilant in purchasing TCCA products as gifts for children during special occasions by checking the product label’s information if compliant to the abovementioned labeling requirement.

Consumers are also encouraged to visit the FDA website and click the Verification Portal  (https://verification.fda.gov.ph) to check the list of notified TCCA products.

For any concern, kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107.

To report any sale or distribution of unnotified TCCAs, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Attachment:-> FDA Advisory No.2020-2022

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2022 || REITERATION OF THE MANDATORY LABELING REQUIREMENTS FOR TOYS AND CHILD CARE ARTICLE PRODUCTS PURSUANT TO THE IRR OF RA 10620

FDA Advisory No. 2020-2054 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Medical Device Establishments

The Food and Drug Administration (FDA) is currently developing the FDA eServices Portal System – an online platform for a streamlined License to Operate (LTO) application of FDA-regulated establishments.

In this regard, FDA is issuing this Advisory to inform all stakeholders that the application for eLTO for Medical Device Establishments within National Capital Region (NCR) is now on its pilot implementation. The eServices Portal is accessible through this link eservices.fda.gov.ph/, with the scope of the application is limited for the time being:

FDA eServices Portal for LTO Application for Medical Device Establishments
Location of Establishment National Capital Region (Metro Manila)
LTO Establishment Application Distributor (Wholesaler, Importer, Exporter), and Trader of Medical Devices, in-vitro diagnostic device, reagents, equipment or devices used for treating sharps, pathological and infectious waste and water purification system
Type of LTO Application Initial, Renewal, and Variation
Fees to be Paid Based on current issuance on Fees and Charges (Reference: DOH Administrative Order No. 50 s. 2001)
Validity of Initial LTO Two (2) years
Start of Pilot Implementation 23 November 2020
End of Pilot Implementation 07 December  2020

For this Pilot Run, applications for Renewal and Variation in the LTO using the eServices Portal are only functional if the approved initial LTO is applied using the eServices Portal.

For those with existing LTO application via ePortal, you may opt to apply to the eServices Portal for a new fee. Previous payment will be forfeited as the application has already been processed.

The implementation of eServices Portal for Manufacturers, including Refurbishers of all health products shall be on November 2020.

Retailers of Medical Devices, Radiation Facilities and Installer of water treatment systems providing installation, repair and maintenance services to operators of water refilling stations and other users of water treatment systems shall be governed by separate rules and regulations.

Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, and Annex B for the Step-by-Step Guide in applying via eServices Portal and the procedure for checking of application status.

Attachment:-> FDA-Advisory-No.2020-2054

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FDA Advisory No. 2020-2053 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “KLEAN BY LUXEORGANIX FACE MASKS 3PLY EARLOOP DISPOSABLE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2053

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2053 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “KLEAN BY LUXEORGANIX FACE MASKS 3PLY EARLOOP DISPOSABLE”

FDA Advisory No. 2020-2052 || PUBLIC HEALTH WARNING ON THE USE OF ULTRAVIOLET (UV) EMITTING DEVICES

The Food and Drug Administration (FDA) strongly advises against the use of UV light for COVID-19 disinfection near or on human body parts. The FDA through Republic Act 9711 or the FDA Act of 2009 is mandated to regulate radiation devices such as UV emitting devices. According to the World Health Organization (WHO), UV radiation can cause skin irritation and damage to eyes due to exposure.[1]

Additionally, the International Commission on Non-Ionizing Radiation (ICNIRP) does not recommend the use of UV lamps for consumers or personal use.[2] UV radiation is typically classified into three (3) wavebands with varying effects to human health:

UV Band Health Effects
UV-A (100 to 280 nm) Soft UV. Associated with skin aging and other effects.
UV-B (280 to 315 nm) Associated with sunburn, skin cancer, and cataracts.
UV-C (100 to 280 nm) Commonly used in ‘germicidal’ or disinfection lamps. Also associated with sunburns and eye injury (photokeratitis).

             As such, the public is advised to follow infection control protocols against COVID-19 from the Department of Health (DOH) like proper handwashing, coughing/sneezing etiquette, and social/physical distancing.

For your guidance.

Attachment:-> FDA-Advisory-No.2020-2052

FDA Advisory No. 2020-1732 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MIO PICCOLO TOKYO EYEBROW MASCARA

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product.

1. MIO PICCOLO TOKYO EYEBROW MASCARA

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:->FDA-Advisory-No.2020-1732

 

FDA Advisory No. 2020-2044 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the following unregistered medical device products:

1. BABYLOVE DIGITAL THERMOMETER
2. PROHEALTHCARE DIGITAL THERMOMETER
3. CITIZEN DIGITAL THERMOMETER CTA302

The FDA verified through post-marketing surveillance that the above-mentioned medical device products are not registered and no corresponding Product Registration Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Registration Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2044

FDA Advisory No. 2020-2043 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “ZHONGKA FACE MASK”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. ZHONGKA FACE MASK

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2043

 

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FDA Advisory No. 2020-2042 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “L & G CREATION BASIC NANOMASK N95/FFP2 GRADE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

1. L & G CREATION BASIC NANOMASK N95/FFP2 GRADE

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2042

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FDA Advisory No. 2020-2040 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “FFP2 PROTECTIVE MASK GB2626-2006 (CIVIL GRADE) 5 LAYERS KN95”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                          

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2040

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2040 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “FFP2 PROTECTIVE MASK GB2626-2006 (CIVIL GRADE) 5 LAYERS KN95”

FDA Advisory No. 2020-2039 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ACCUPOINT™ BLOOD TRANSFUSION SET”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not registered and no corresponding Product Registration Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2039

FDA Advisory No. 2020-2038 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

1. DAY MAKER DISPOSABLE FACE MASK
2. AINBEI DISPOSABLE PROTECTIVE MASK

The FDA verified through post-marketing surveillance that the above-mentioned medical device products are not notified and no corresponding Product Notification Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unnotified medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Notification Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unnotified products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                           

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2038

 

FDA Advisory No. 2020-2037 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “RX DR. CARE – LUBRICATING JELLY”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx, MDR-xxx, or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unnotified product.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2037

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2037 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “RX DR. CARE – LUBRICATING JELLY”