FDA flags use of unregistered medical device
Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety
Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety
The Food and Drug Administration flagged the purchase and use of an unregistered medical device product.
In a recent advisory, the FDA cautioned healthcare professionals and the public against purchasing and using “nasal oxygen cannula.”
Upon post-marketing surveillance, the FDA found that the said product is not registered and has no corresponding Product Registration Certificate.
“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,” the FDA noted.
“Since this unregistered medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety,” the agency furthered.
It also reminded establishments not to distribute, advertise, or sell the said product until the Products Registration Certificate is issued, otherwise, “regulatory actions and sanctions shall be strictly pursued.”
The FDA also urged the public to check if a product is registered with the agency using the FDA Verification Portal Feature accessible at https://verification.fda.gov.ph.
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