FDA Advisory No. 2019-178 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device: BFP™ Ovulation & Pregnancy Test Strips for Trying- To-Conceive Woman

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

  1. BFP™ Ovulation & Pregnancy Test Strips for Trying- To-Conceive Woman

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 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 are 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 hereby advised not to purchase this violative product in the market.

All concerned establishments are warned not to distribute violative medical device until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the medical device.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 local 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.

FDA Advisory No.2019-178

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