FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices, and for easy reference to predicate device types. “Classification product codes are used by FDA to obtain quality and reliable data, and perform analyses that are often reported to Congress, the Government Accountability Office (GAO), the general public, the media, and industry,” the guidance says. “Classification product codes are also used throughout the total product life cycle (TPLC) as they connect all medical device databases.”
The document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices. It is limited to medical devices as defined in Section 201(h) of the Food Drug & Cosmetic Act and does not discuss classification product codes used to regulate nonmedical electronic radiation emitting products.
Jim Dickinson writes the Washington Wrap-Up Column for MD+DI.