THE Food and Drug Administration (FDA) yesterday warned the public against buying and using an unregistered medical device that measures blood pressure.
In its Advisory No.2023-1876, the FDA said the “Great® Aneroid Sphygmomanometer” has no Certificate of Product Notification.
“The FDA verified through post-marketing surveillance that the abovementioned medical device product is not notified and no corresponding Product Notification Certificate has been issued,” said the FDA.
The FDA established the Certificate of Product Notification (CPN) as a requisite for companies to provide consumers with better awareness of certain products, specifically those under the Medical Device Notification, Cosmetic Product Notification, Toys and Childcare Articles Notification, and Product Batch Notification for Vapor Products and Heated Tobacco Products categories.
“The FDA warns all healthcare professionals and the general public not to purchase and use the unnotified medical device product,” the FDA said, adding the use of the medical product may pose potential health hazards to users.
“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 FDA warned penalties and sanctions will be imposed against establishments which will be caught distributing, advertising, or selling the medical device product.
It asked law enforcement agencies and local government units to ensure that the product is not sold or made available in their areas of jurisdiction.
The FDA also urged the Bureau of Customs to restrain the entry of the said unnotified product.
