Medical Devices

Webinar - Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types - February 2, 2017

          

On Thursday, February 2, 2017, the FDA hosted a webinar to share information and answer questions about the final guidance document, “Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types.” The purpose of this document is to provide recommendations to industry about the regulation of accessories to medical devices. The guidance provides clarification on the definition of a medical device accessory. It recommends classifying accessories according to their level of risk when used as intended with a parent device to ensure their safety and effectiveness while reducing burden to manufacturers. It also encourages manufacturers to use the de novo process to request risk-based classification for new accessories when appropriate.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health
 

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