The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device product Cobas® PCR Swab:
FDA post-marketing surveillance (PMS) activities have verified that the above-mentioned medical device product 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 are prohibited.
Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety.
In light of the above, the public is advised not to purchase the aforementioned violative product 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 product until it has 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.