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U.S. Department of Health and Human Services

Medical Devices

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FDA Issues Guidance on Medical Device Classification Product Codes

April 11, 2013

Dear Medical Device Associations,

Today the FDA issued Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff.

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). You may submit comments on this guidance at any time.

Thank you for your support of the FDA and our mission.

Food and Drug Administration
Center for Devices and Radiological Health