This article deals with the Food and Drug Administration (FDA) regulations warning all healthcare professionals and the general public not to purchase and use unnoticed medical device products such as
- Band Doctor: 25mmx60mmX6, 38mmx60mmX2, 38mmx38mmX2.
- Band Doctor: 41mm x 72mm x 8
- BAND CARE: 19mmX72mmX12, 38mmX38 mmX2, 10mmX40mmX6, 38mmX72mmX2
The FDA regulations confirmed that the above-mentioned medical device product had been notified and that no corresponding Product Notification Certificate has been granted through post-marketing monitoring. The Food and Drug Administration Act of 2009, also known as Republic Act No. 9711, makes it unlawful to promote, advertise, or support health products. Because an unnoticed medical device product has not been evaluated by the FDA, the agency cannot guarantee its quality and safety.
All relevant establishments are advised not to distribute, market, or sell the aforementioned infringing medical device product until the Product Notification Certificate is granted; otherwise, regulatory actions and fines will be strongly pursued. Always utilize the integrated search tool on the FDA website at www.fda.gov.ph to see if a product has been notified by the FDA before purchasing it. You may also search for the FDA notification number on the product label, which is usually in the form CMDN-xxx.
All law enforcement agencies and local government units are asked to ensure this product is not marketed or made accessible in the market or jurisdictional regions. The Bureau of Customs is being requested to prevent the import of this unnotified commodity. If a consumer wishes for additional information and has queries concerning this advice, please contact the FDA CDRRHR through e-mail at cdrrhr@fda.gov.ph or phone (02) 8857-1900, loc. 8301. Contact the online reporting facility eReport through email at ereport@fda.gov.ph to report any sale or distribution of a medical device that has not been reported. It is required that this advice be sent to everyone involved.
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Source: FDA-Philippines
