FDA issues warning vs unnotified medical device

The Food and Drug Administration on Tuesday warned healthcare professionals and the general public against purchasing and using an unnotified medical device product.

In an advisory, the FDA warned against the purchase and use of "Medx Urine Bag."

Through its post-marketing surveillance, the FDA verified that the abovementioned medical device product is not notified and has no corresponding Product Notification Certificate.

The manufacture, importation, sale, distribution, promotion, advertising, or sponsorship of health products without the proper authorization is prohibited.

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

The agency warned all concern establishments not to distribute, advertise, or sell the said violative medical device product until the CPN has been issued, otherwise, "regulatory actions and sanctions shall be strictly pursued."

"Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph," it added.

The FDA also requested all law enforcement agencies and local government units to ensure that the said product is not sold or made available in the market or areas of jurisdiction.

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