Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Device Classification Product Codes." The purpose of the guidance document is to educate regulated industry and FDA Staff on how, when, and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This document describes how classification product codes are used in a variety of FDA program areas to regulate and track medical devices. This draft guidance is not final nor is it in effect at this time.