Category: Device Advisories

11Oct

FDA Advisory No. 2019-345 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Family Brand Absorbent Cotton”

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

Family Brand Absorbent Cotton

The FDA verified through post-marketing surveillance that the Certificate of Product Registration (CPR) of the abovementioned medical device has expired on 10 August 2017 hence, unregistered. 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. 2019-345

11Oct

FDA Advisory No. 2019-344 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Intersurgical Adult Nasal Cannula with Straight Prongs and Tube”

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

Intersurgical Adult Nasal Cannula with Straight Prongs and Tube

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 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 from FDA is prohibited.

Accordingly, since this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device 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.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-344

11Oct

FDA Advisory No. 2019-343 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

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

Luxe Organix Hydrocolloid Acne Spot Patch Night Time

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

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-343

11Oct

FDA Advisory No. 2019-342 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Luxe Organix Hydrocolloid Acne Spot Patch Day Time”

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

Luxe Organix Hydrocolloid Acne Spot Patch Day Time

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

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-342

10Oct

FDA Advisory No. 2019-341 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Waxvac Ear Cleaner”

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

Waxvac Ear Cleaner

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.

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. 2019-341

10Oct

FDA Advisory No. 2019-340 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Adhesive Bandages in foreign characters”

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

Adhesive Bandages in foreign characters

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.

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. 2019-340

10Oct

FDA Advisory No. 2019-338 || 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:

Daiso – Fruit Fragrance Bandages
Daiso – Cold Wrap – Icing Relief Stretch Bandage

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.

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. 2019-338

10Oct

FDA Advisory No. 2019-337 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “OU 40 SPORT BANDAGES”

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

OU 40 SPORT BANDAGES

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.

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. 2019-337

10Oct

FDA Advisory No. 2019-336 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Unimex Gauze Swab”

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

Unimex Gauze Swab

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.

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. 2019-336

10Oct

FDA Advisory No. 2019-335 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Steadlive Anti Regurgitation Drainage Bag-Medical Urine Collection Bag”

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

Steadlive Anti Regurgitation Drainage Bag-Medical Urine Collection Bag

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.

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. 2019-335

10Oct

FDA Advisory No. 2019-334 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “HCG Test Strip”

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

HCG Test Strip

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.

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. 2019-334

10Oct

FDA Advisory No. 2019-333 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “I-Shield Gauze Bandage 3″ x 10 yards”

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

I-Shield Gauze Bandage 3″ x 10 yards

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.

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. 2019-333

10Oct

FDA Advisory No. 2019-332 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Assured Gauze Pads Compresses”

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

Assured Gauze Pads Compresses

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.

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. 2019-332

10Oct

FDA Advisory No. 2019-331 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Obon Natural Rubber Latex Male Condoms”

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

Obon Natural Rubber Latex Male Condoms

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.

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. 2019-331

10Oct

FDA Advisory No. 2019-330 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “1Pair Left+Right Bandage Orthopedic Hand Brace Wrist Support Finger Splint Carpal Tunnel Syndrom”

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

1Pair Left+Right Bandage Orthopedic Hand Brace Wrist Support Finger Splint Carpal Tunnel Syndrom

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.

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. 2019-330

26Sep

FDA Advisory No. 2019-309 || RADIATION PROTECTION TRAINING CERTIFICATE REQUIREMENT OF THE CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (CDRRHR)

This is in connection with the Radiation Protection Officer (RPO) training certificate as one of the documentary requirements to be submitted by an applicant to FDA-CDRRHR in relation to the License to Operate (LTO) as radiation facility or establishment.

For clarification, please be informed that the FDA CDRRHR or the FDA Academy does not offer or conduct radiation protection training for Radiation Protection Officers. However, the FDA-CDRRHR accepts training certificates, certifications, proof of completion or participation on the said topic that are issued by a third party service provider from the sectors of the industry, academe, government or National Regulatory Authority, or non-government organization (NGO) both here and abroad that is recognized, certified or accredited by the Philippine Accreditation Board, Professional Regulatory Commission, ISO Certification bodies, Commission on Higher Education, professional or industry organizations, and other relevant international organizations, like the International Atomic Energy Agency.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research (CDRRHR) through e-mail at [email protected] and cc: the Policy and Planning Service-FDA Academy at [email protected].

Dissemination of this advisory by all concerned parties and stakeholders is hereby requested.

Attachment: > FDA Advisory No. 2019-309

25Sep

FDA Advisory No. 2019-308 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFECTIGUARD KID’S STERILE BANDAGES”

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. INFECTIGUARD KID’S STERILE BANDAGES

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.

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. 2019-308

25Sep

FDA Advisory No. 2019-307 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DELCARE – STOMACH TUBE”

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. DELCARE – STOMACH TUBE

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.

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

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. 2019-307

25Sep

FDA Advisory No. 2019-306 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Langhe Disposable Circumcision Suture Device”

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

Langhe Disposable Circumcision Suture Device

The FDA verified through post-marketing surveillance that the abovementioned medical device, advertised for sale on www.lazada.com.ph, 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.

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

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. 2019-306

17Sep

FDA Advisory No. 2019-287 || Public Health Warning Against the Purchase and Use of the following Unregistered Snibe Diagnostic Maglumi Medical Devices:

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

1. Syphilis
2. HBsAg
3. Anti-HBs
4. HIV Ab/Ag Combi
5. Anti-HCV

to continue reading, click the attachment below…

Attachment-> : FDA Advisory No. 2019-287

27Aug

FDA Advisory No. 2019-255 || Voluntary Product Recall of Proximate ILS Curved Intraluminal Stapler

The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Proximate ILS Curved Intraluminal Stapler with DVR No. 4981, manufactured by Ethicon Endo-Surgery, LLC — Puerto Rico and imported by Johnson & Johnson (Phils.), Inc.:

Product Name

Product Code

Lot Number

Proximate ILS Curved

Intraluminal Stapler

CDH21A

CDH25A

CDH29A

CDH33A

All lots within expiration date range of December 2022 to March 2024

Through investigation of complaints and returned products, Ethicon has confirmed occurrence of uncut washers and malformed staples with the above mentioned medical device, which can compromise staple line integrity. If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage, or hemorrhagic shock.

Based on Ethicon’s analysis of complaints received to date and estimated device usage, the predicted occurrence of complaints for malformed staples has increased but is expected to remain below 0.1%. Ethicon is implementing corrective actions to resolve the shift in product performance.

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 above mentioned 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 [email protected], or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-255

27Aug

FDA Advisory No. 2019-254 || Public Health Warning Against the Purchase and Use of the Medical Device “INTROCAN SAFETY IV CANNULA WITH FIXATION WING (STERILE)” with the following Unregistered Article Numbers:

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

SIZE	UNREGISTERED ARTICLE NUMBER
G16	4254570-01
G18	4254562-01, 4253604-01
G20	4254546-01
G22	4254511-01, 4253540-01
G24	4254503-01

The FDA verified through post-marketing surveillance that the medical device with the above- mentioned article numbers 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.

Furthermore, FDA has verified that the above-stated unregistered medical device product is not imported by B. Braun Medical Supplies, Inc.

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

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. 2019-254

16Aug

FDA Advisory No. 2019-110-A || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019 -110 “HR™ Lubricating Jelly One Shot”

The Food and Drug Administration (FDA) informs the public that the HR™ Lubricating Jelly One Shot has been registered by the Market Authorization Holder (MAH), Berovan Marketing Inc., with FDA registration number MDR-06020A 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. 2019-110 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) 857-1900 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. 2019-110-A

15Aug

FDA Advisory No. 2019-247 || 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:

Ximivogue Germicidal Breathable Band-Aid Set
Ximivogue Band-Aid Cartoon

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. 2019-247

15Aug

FDA Advisory No. 2019-246 || Public Health Warning Against False, Deceptive and Misleading Health Claims of Pantyliners/Sanitary Napkins

Reiteration of the issuance of FDA Advisory No. 2017-323 regarding the false, deceptive and misleading health claims of pantyliners/sanitary napkins.

The Food and Drug Administration (FDA) reissues this advisory to inform the general public the proliferation of pantyliners/sanitary napkins with health claims e.g. relieves tension, reduces irritation, prevents/cures diseases/infection such as UTI, Myoma, vaginal odor, hormonal imbalance etc., and releases negative ions.

While as general rule, pantyliners/sanitary napkins are not required to seek proper authorization from the FDA, pantyliners/sanitary napkins with health claims, require such authorization. The sale/marketing of such unregistered product constitutes violation of Section 10 of Republic Act No. 9711 otherwise known as the “Food and Drug Administration Act of 2009”.

On the other hand, the false, deceptive and misleading advertisement of these pantyliners/ sanitary napkins, constitutes violation of Title III, Chapter I of Republic Act No. 7394, otherwise known as the “Consumer Act of the Philippines of 1992”.

The public is thus advised to be vigilant and observe precautionary measures in purchasing unregistered pantyliners/sanitary napkins with health claims, false, deceptive and misleading health claims.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through email at [email protected] or call (02) 857-1900 local 8301.

Attachment-> : FDA Advisory No. 2019-246

15Aug

FDA Advisory No. 2019-245 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Megafresh® Compact Alkaline Water Filtration Systems”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered health related device:

Megafresh® Compact Alkaline Water Filtration Systems

The FDA verified through post-marketing surveillance that the abovementioned health related device is not registered and the Certificate of Health Related Device Registration (CHRDR) 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 health related device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. Health related device products especially water purification device/ system shall not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water.

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 health related device until CHRDR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

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 health related 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. 2019-245

30Jul

FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”:

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered health related device:

The FDA verified through post-marketing surveillance that the above mentioned health related

device is not registered and the Certificate of Heath Related Device Registration (CHRDR) 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 health related 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 distribute, advertise the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative

health related device until CHRDR 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 health 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-2019-228

26Jul

FDA Advisory No. 2019-227 ||Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Family Care™ Digital Thermometer”

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

“Family Care™ Digital Thermometer”

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.

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.2019-227

26Jul

FDA Advisory No. 2019-226 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Curad Sheer Bandage”

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

“Curad Sheer Bandage”