Category: Device Advisories

FDA Advisory No. 2020-812 || Public Health Warning Against the Sale and Purchase of the Uncertified COVID-19 Test Kit “Bioeasy 2019-nCoV IgG/IgM GICA Rapid Test”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the sale and purchase of the uncertified Covid-19 test kit:

  1. Bioeasy 2019-nCoV IgG/IgM GICA Rapid Test

The FDA verified through post-marketing surveillance conducted on 20 March 2020 that the above mentioned medical device is not certified and/or no 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 has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety.

Furthermore, FDA Circular No. 2020-016 entitled “Prohibition of Online Selling of FDA Certified Covid-19 Antibody Test Kits” prohibits online selling and commercial use of such products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected].

To report any sale or distribution of unregistered/uncertified medical devices, 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.2020-812

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-812 || Public Health Warning Against the Sale and Purchase of the Uncertified COVID-19 Test Kit “Bioeasy 2019-nCoV IgG/IgM GICA Rapid Test”

FDA Advisory No. 2020-807 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Infrared Thermometer”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. Infrared Thermometer

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-807

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-807 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Infrared Thermometer”

FDA Advisory No. 2020-793 || PROHIBITION OF THE OPERATION OF PORTABLE / HANDHELD DIAGNOSTIC X-RAY MACHINES

Despite the increased demand to utilize innovations in diagnostic x-ray devices brought about by the COVID-19 pandemic, the Food and Drug Administration (FDA) reminds the general public and all radiation facilities to refrain from using portable/handheld diagnostic xray machines pursuant to Section 5.3.25 of DOH Administrative Order (AO) No. 35 s. 1994 or the “Requirements for the Control of Radiation Hazards from Clinical Diagnostic X-ray Facilities”. These handheld x-ray devices are configured to have a single peak kilovoltage (kVp) and low tube current (mA) settings insufficient for x-ray procedures of varying body dimensions. Basic radiation protection and safety principles are compromised with the use of such devices because of the increased probability of committing errors caused by the following:

  • Unstable rectangular collimation of areas of interest due to hand movement/tremors which can cause unwanted exposure of adjacent body parts.1
  • Questionable image quality and increased patient radiation dose due to the use of single kVp and low mA settings.’
  • Vulnerability to unauthorized use due to accessibility and portability.

The FDA fervently supports measures that will help in the prevention and diagnosis of COVID-19 and other communicable diseases without compromising other aspects of the public health. For questions, clarifications and/or reports regarding this matter, please contact the Center for Device Regulation, Radiation Health, and Research (CDRRHR) through the hotline (02) 8815-9600 or email at [email protected] or [email protected].

For strict compliance.

Attachment:-> FDA Advisory No.2020-793

FDA Advisory No. 2020-783 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device “Cawono® D380 Non-Contact IR Thermometer”

Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices:

  1. “Cawono® D380 Non-Contact IR Thermometer”

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-783

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-783 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device “Cawono® D380 Non-Contact IR Thermometer”

FDA Advisory No. 2020-782 || Public Health Warning Against the Unapproved and Misleading Health Claims of Medical Devices that Decrease the Risk for Coronavirus Disease (COVID-19) Infection

The Food and Drug Administration (FDA) warns the public against unapproved and misleading advertisements and promotion of various medical devices monitored as part of the post market surveillance activity of the Regional Field Office.

  1. BioMask™ Flat+™  Medical Face Mask
  2. RespoKare® Active Protection Mask Anti-Viral Mask

The public is hereby advised to be vigilant against such deceptive marketing of medical devices. Ear loop facemask shall not, in any way, cure and specially kill viruses and bacteria like influenza A and SARS and any other diseases, and should not bear any misleading, deceptive and false claims on their labels and/or any promotional materials that will provide erroneous impression on the product’s character or identity.

Further, the FDA would like to emphasize that of this time, there are no specific treatments for COVID-19. Everyone is encouraged to follow accurate public health advice and guidance from the Department of Health and the World Health Organization on basic protective measures against COVID -19.

All Marketing Authorization Holders of these medical devices are sternly warned and hereby
directed to stop such misleading advertisements and promotions. Appropriate regulatory tools and sanctions shall be executed to such companies that are continuously conducting such and similar activities upon issuance of this Advisory.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-782

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-782 || Public Health Warning Against the Unapproved and Misleading Health Claims of Medical Devices that Decrease the Risk for Coronavirus Disease (COVID-19) Infection

FDA Advisory No. 2020-775 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the following unregistered medical devices:

  1. Pharmaline Monitor Digital Thermometer
  2. Microlife Digital Jumbo LCD Thermometer

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-775

FDA Advisory No. 2020-774 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the following unregistered medical devices:

  1. Benetech Non-Contact Infrared Thermometer
  2. Aicare Infrared Thermometer
  3. Sejoy Infrared Forehead Thermometer

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-774

FDA Advisory No. 2020-766 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “LERKONN INFRARED THERMOMETER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. LERKONN INFRARED THERMOMETER

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-766

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-766 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “LERKONN INFRARED THERMOMETER”

FDA Advisory No. 2020-762 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the following unregistered medical devices:

  1. Smileplus – Classic Washproof Plasters
  2. Smileplus – Knuckle Plasters

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-762

FDA Advisory No. 2020-744 || ADVISORY FOR THE ISSUANCE OF SPECIAL PERMIT FOR MEDICAL RADIATION FACILITIES USING LOANED MOBILE X-RAY DEVICES DURING THE COVID-19 PANDEMIC

With the increasing Covid-19 cases in the country, there is also an increase in the demand of medical services including the use of mobile x-ray devices in the diagnosis of the disease. This prompted medical x-ray facilities to purchase mobile x-ray devices. But due to the delay in the delivery of the newly purchased mobile x-ray devices, suppliers provided service/loaner x-ray units for use until such time that the intended mobile x-ray devices are delivered to respective facilities. In response to pandemic, the Food and Drug Administration – Center for Device Regulation, Radiation, Health and Research (CDRRHR) thru the Radiation Regulation Division (RRD) shall be issuing a Special Permit for loaner unit mobile x-ray devices, intended for use in the diagnosis of Covid-19 patients in need of immediate imaging procedures and medical response.

The following requirements for special permit application shall be submitted:

  1. Letter of intent for the issuance of Special Permit addressed to:

ENGR. BAYANI C. SAN JUAN, MSc, MNSA, CESE Director IV
Center for Device Regulation Radiation Health and Research

  1. Duly accomplished medical x-ray license application form.
  2. Copy of On-Loan agreement between the user and the supplier.
  3. Copy of the Official Receipt or certificate of subscription of the personal dose monitor (TLD or OSL) from the provider of personnel dose monitoring service.
  4. Copy of the VALID Professional Regulation Commission (PRC) license of all the radiologic/x­ray technologist/s.
  5. Calibration certificate of the loaned mobile x-ray machine.

Guidelines

  1. Applicants may email the scanned copy of their documentary requirements to [email protected] or [email protected].
  2. The processing of Special Permit that will be used for Covid-19 outbreak is exempted from payment
  3. The effectivity of the Special Permit shall be upon the complete and correct submission of requirements.
  4. The validity of the Special Permit shall follow the duration of the use of equipment specified in the agreement.
  5. The use of loaned mobile x-ray machines shall adhere with the radiation protection and safety standards prescribed by FDA.
  6. In the event that the newly purchased mobile x-ray devices have been delivered and installed to respective facility, the facility shall submit an application for the issuance of appropriate authorization.
  7. Scanned copy of approved Special Permit shall be sent to the registered email of the facility.

This shall take effect starting 14 April 2020.

For your guidance.

Attachment:->FDA Advisory No.2020-744

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-744 || ADVISORY FOR THE ISSUANCE OF SPECIAL PERMIT FOR MEDICAL RADIATION FACILITIES USING LOANED MOBILE X-RAY DEVICES DURING THE COVID-19 PANDEMIC

FDA Advisory No. 2020-613 || Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the following unregistered medical devices:

  1. Rx Dr. Care — Synthetic Vinyl Gloves
  2. Rx Dr. Care — Clear Vinyl Gloves

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificate of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR 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 these unregistered products.

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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-613

FDA Advisory No. 2020-671 || Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits

The Food and Drug Administration (FDA) has approved sixteen (16) COVID-19 Rapid Antibody test kits for commercial use as of April 16, 2020. These applications have completed necessary documentary requirements and have undergone review and evaluation by the FDA. As part of FDA’s mandate to ensure safety and quality of these products, surveillance measures are in place to monitor performance and effectiveness.

These test kits are independent from each other and each product has different specifications. These are manufactured by different companies, in various countries and settings. Each uses a technology and validation technique which may vary from others. The rapid test kits detect the presence of antibodies in an individual’s blood or serum. 

Antibodies detected by these types of test kits are identified as Total Antibody, IgG antibody and IgM antibody. Total antibody signifies the collective response of the patient’s immune system. IgM antibodies represent response to a current or recent infection while IgG antibodies represent response from a past infection. Some of the kits detect only one antibody – either IgM or IgG. Some kits detect total antibodies – IgM and IgG together in one result. Other kits detect both IgG and IgM at the same time but give a separate result for each.

It is important to consider the timing of the infection and the condition of the patient during the time of specimen collection. The selection of the type of kit to be used is also dependent on the indication, the information the doctor wants to obtain, and the specifications of the kit. Interpretation must be done with caution and clinical correlation. 

The FDA encourages the public to take into consideration that these kits have technical specifications unique from each other. These are rapid kits that are packaged as easy to use but they should be administered by trained health professionals. The agency reiterates that these kits are strictly for medical professional use only and not intended for personal use. The test should be administered by trained health professionals and the results should be interpreted by licensed physicians. Confirmatory PCR based testing is still the gold standard.

The FDA stands firm in safeguarding the public against unregistered and substandard health products amidst the COVID-19 pandemic. The agency continuously conducts post marketing surveillance and evaluation despite the stringent and expedited measures imposed on these approvals. For any reports on FDA approved COVID-19 health products, send an email to [email protected] 

Attachment:->FDA Advisory No.2020-671

FDA Advisory No. 2020-547 || Updated Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs Release

Due to the rapid spread of COVID-19, the following updated measures are adopted for the expedient release of certain protective equipment (PPE) withn the jurisdiction of the Bureau of Customs.  The PPE include:

  1. Face masks including N95 masks
  2. Shoe Covers
  3. Gloves
  4. Head Covers, and
  5. Gowns

For the abovementioned PPE intended for entry to the local market for commercial use, the presentation of the copy of the importer’s License to Operate (LTO) should be sufficient compliance for customs release.

For foreign donation of the same PPE, clearance from FDA shall not be needed.  These include companies, other than medical device establishments, with employees who use face masks in the performance of their jobs and are strictly for company use.

Strict postmarket surveillance will be implemented to all these PPEs.  All companies who have imported PPEs under this Advisory and will continue to distribute PPEs for commercial purposes shall apply for Certificate of Medical Device Notification (CMDN) within three (3) months after the lifting of Proclamation No. 922 s. 2020 declaring a State of Public Health Emergency throughout the Philippines.  Necesssary regulatory measures will be implemented to those companies who will not comply with this requirement.

Said procedure for clearance of PPE prior to customs release shall be in effect otherwise lifted.

This advisory supersedes FDA Advisory No. 2020-420 issued on 20 March 2020.

For your guidance.

Attachment:->FDA Advisory No.2020-547

FDA Advisory No. 2020-513 || FDA Approves the First Locally Manufactured Test Kit for COVID-19 for Commercial Use

The Food and Drug Administration (FDA) has now approved the Real-Time PCR for the detection of COVID-19 manufactured by the Manila HealthTek, Inc. for commercial use.

The test kit was previously approved by the FDA for field trial. with gene sequencing on 10 March 2020.  Upon the company’s submission of necessary requirements today, the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use.

This is the first locally made PCR based COVID-19 test kit approved by the FDA which was developed in collaboration with the University of the Philippines-National Institute of Health (UP-NIH), funded by the Department of Science and Technology (DOST).

Aside from this PCR based test kit, the FDA has approved one additional rapid test kit today, which brings the total number of COVID-19 approved test kits to 30. The FDA will continue to update the public on COVID-19 testing kits approval.

Attachment:->FDA Advisory No.2020-513

FDA Advisory No. 2020-497 || DISTRIBUTION OF FDA APPROVED COVID-19 RAPID ANTIBODY TEST KITS

The Food and Drug Administration (FDA) reiterates to all licensed importer/distributor that COVID-19 test kits is strictly for use of medical professional use and not intended for personal use.

The product should be strictly distributed to appropriate establishments or institutions. Subsequently, this should be acquired by the general public through a prescription from a licensed physician. The administration of the test must be performed by a doctor or a trained health professional. Furthermore, the interpretation of results must be done by a doctor.

Attachment:-> FDA Advisory No.2020-497

FDA Advisory No. 2018-309-A || Lifting the Advisory of the Registered Medical Device Product “Air Life Gauze Bandage 4” x 10 yds, 40’s/40’s 19 x 10 mesh under FDA Advisory No. 2018-309 “Public Health Warning Against the Purchase and Use of Medical Device with Expired Certificate of Product Registration (CPR) “

The Food and Drug Administration (FDA) informs the public that the medical device product Air Life Gauze Bandage 4″ x 10 yds, 40’s/40’s 19 x 10 mesh with CPR No. MDR-08861, has been registered by the Market Authorization Holder (MAH), Airlife International Trading Corporation, in accordance to existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2018-309 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, email us at [email protected].

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.2018-309-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-309-A || Lifting the Advisory of the Registered Medical Device Product “Air Life Gauze Bandage 4” x 10 yds, 40’s/40’s 19 x 10 mesh under FDA Advisory No. 2018-309 “Public Health Warning Against the Purchase and Use of Medical Device with Expired Certificate of Product Registration (CPR) “

FDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19

In line with the ongoing response to the increasing number of COVID-19 cases in the Philippines, the Food and Drug Administration (FDA)- Philippines hereby provides an initial list of approved Rapid Antibody Test Kits.

PRODUCT NAME MANUFACTURER
1. NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT Biolidics Limited. – 37 Jalan Pemimpin, #02-07, Mapex, Singapore
2. NOVEL CORONAVIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD) Nanjing Vazyme Medical Technology Co., Ltd – Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China
3. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) Zhuhai Livzon Diagnostic Inc. – 1st Building, No. 266, Tongchang Road, Xiangzhou District, Zhuhai, Guangdong Province, People’s Republic of China
4. 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) Innovita (Tangshan) Biological Technology Co., Ltd. – No. 699 Juxin Street, High-Tech Industrial Development Zone, Qian’an 064400, Hebei, China
5. SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD) Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, People’s Republic of China

This list shall be regularly updated. For reference please click the link.

https://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez

To report any sale or distribution of COVID-19 rapid test kits not included in the list, you may email us at [email protected].

Attachment:->FDA Advisory No.2020-483

FDA Advisory No. 2020-178-A || Lifting the Advisory of the Registered Medical Device under FDA Advisory No. 2020-178. Subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Alaris® Secondary Syringe Adapter”

The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device product “Alaris® Secondary Syringe Adapter” has been registered by the Market Authorization Holder (MAH), KSM Healthcare Inc., with FDA registration number MDR-04674 in accordance to existing FDA rules and regulations

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-178 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, email us at [email protected]

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. 2020-178-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-178-A || Lifting the Advisory of the Registered Medical Device under FDA Advisory No. 2020-178. Subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Alaris® Secondary Syringe Adapter”

FDA Advisory No. 2020-447 || WALA PANG APRUBADONG POINT-OF-CARE O INSTANT COVID 19 TEST KITS

Sa gitna ng ating pagresponde sa COVID 19, pinapaalalahanan ng Food and Drug Administration (FDA) ang publiko na wala pang COVID-19 point-of-care test kit o rapid test kit na aprubado ng ahensya sa ngayon. Ang mga point-of-care test kit o rapid test kit ay nagbibigay ng agaran na resulta sa ilang minuto lamang (tulad ng pregnancy test kits).

Ang mga naunang nailabas na listahan ng FDA na aprubadong COVID 19 test kits ay gumagamit ng Real Time Polymerase Chain Reaction (RT-PCR). Ito ay isang proseso na nangangailangan ng PCR Machine sa laboratoryo at mga tauhang may sapat na kaalaman sa paggamit nito.

Ang Department of Health (DOH) ay naglabas din ng pahayag sa pamamagitan ng Department Circular No. 2020-0143 ukol sa COVID-19 laboratory testing na nagsasaad na wala pang malinaw na ebidensyang susuporta sa paggamit ng lateral flow rapid (IgG/IgM) test sa pagkumpirma ng COVID 19. Ayon din sa DOH, tanging ang mga laboratoryo na nasuri ng Research Institute for Tropical Medicine (DOH-RITM) ang maaring magproseso ng mga RT-PCR based kits.

Patuloy na paiigtingin ang mga kilos ng ahensya upang makatulong sa pag sugpo sa sakit na ito. Tingnan ang FDA website para sa dagdag na detalye.

Para sa inyong kaalaman at patnubay.

Attachment:-> FDA Advisory No.2020-447

FDA Advisory No. 2020-434 || Public Health Advisory on the Purchase and Use of the Infared Thermometer for Medical Use Offered for Sale Online

The Food and Drug Administration (FDA) received reports regarding rampant online selling of the infrared thermometer for medical use in different online platforms.

A Certificate of Product Registration is required for infrared thermometers prior to distribution and sale. In view of this, FDA hereby advises all healthcare professionals and the public to purchase and use only infrared thermometer for medical use with Certificate of Product Registration (CPR) issued by FDA.

All concerned establishments are warned not to distribute, advertise, or sell unregistered infrared thermometer until a CPR 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 only registered infrared thermometer are sold or made available in the market or in their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of unregistered above-mentioned medical device 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.  

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-434

FDA Advisory No. 2020-178 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Alaris® Secondary Syringe Adapter”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. “Alaris® Secondary Syringe Adapter”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet 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 has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR 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 areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered 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) 857-1900 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.2020-178

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-178 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Alaris® Secondary Syringe Adapter”

FDA Advisory No. 2020-177 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “MEDX Cervical Brush”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. “MEDX Cervical Brush”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet 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 has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR 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 areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered 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) 857-1900 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.2020-177

FDA Advisory No. 2020-157 || Voluntary Recall of Unisepta Foam 2 Medical Device Disinfectant 750ml

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public on the voluntary recall of Unisepta Foam 2 Medical Device Disinfectant 750ml with MDR No. 06986, imported and distributed by Dental Domain:

Product Name

Lot Number

Unisepta® Foam 2 Medical Device Disinfectant 750ml A08702S
A21511S
A31010S
B10630S

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 Burkholderia Capacia commonly 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.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the said medical device.

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

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

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at cdrrhr@fda.gov.ph, or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-157

FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Volumetric Solution Infusion Set. Please see particulars/details of the original vs. the counterfeit product  on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product.

All concerned establishments are warned not to distribute, the said counterfeit medical device.

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 violative 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 counterfeit 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 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.2020-158

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

FDA Advisory No. 2020-156 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Inset Adult without Needle”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Inset Adult without Needle. Please see particulars/details of the original vs. the counterfeit product on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product.

All concerned establishments are warned not to distribute, the said counterfeit medical device.

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 violative 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 counterfeit 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 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.2020-156

FDA Advisory No. 2020-122 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Doc Check® – Nebulizer Mask”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. “Doc Check® – Nebulizer Mask”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet 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 has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR 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 areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered 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 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. 2020-122

FDA Advisory No. 2020-121 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns the general public and all healthcare professionals against the purchase and use of the unregistered medical devices:

  1. We Bare Bears Adhesive Bandage/Plaster
  2. First Aid – Breathable & Waterproof Adhesive Bandage/Plaster (40 count)
  3. First Aid – Breathable & Waterproof Adhesive Bandage/Plaster (50 count)

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificates of Product Registration (CPR) have not yet 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 devices have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR are 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 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, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 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. 2020-121

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