FDA issues new draft guidance on medical device product codes
11 January 2012Medical Device Alert
On 3 January 2012, the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance regarding medical device classification product codes in follow-up to FDA's October 2011, Plan of Action For Implementation of 510(k) and Science Recommendations which stated that a new draft guidance would be developed "to more consistently develop and assign unique product codes." The new draft guidance, Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes, describes how classification product codes are used in the regulation of medical devices and also to track devices once they are marketed. The purpose of the guidance is to provide information on the use of product codes and does not appear to present a change in existing policies or procedures.