Since the passage of the May 28, 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act (FD&C Act), the Classification Regulation Panels (21 CFR Parts 862-892) have been the basis for the Center for Devices and Radiological Health’s (CDRH’s) Classification Product Code structure and organization. In order to respond to the evolution of device technology, classification product codes were created to assist in accurate identification and tracking of current medical devices and to allow for tracking of and 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. Classification product codes are also used throughout the total product life cycle (TPLC) as they connect all medical device databases.
This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This document is limited to medical devices as defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act and does not discuss classification product codes used to regulate non-medical electronic radiation emitting products.
The scope of this document includes devices described in the existing classifications under 21 CFR Parts 862-892. It also describes how the product code builder developed by FDA’s Office of Regulatory Affairs is used for devices that are licensed under the Public Health Service Act (PHS Act), and currently do not have product codes generated under classification regulation panels. It also covers unclassified devices and devices not yet classified.