FDA Updated Guidance - Medical Devices Accessories – Describing Accessories and Classification Pathways

Today the FDA is announcing the availability of the updated final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was updated to include new mechanisms to request (1) a different classification for an existing accessory type (i.e., accessories already on the market), and (2) for new accessory types (i.e., accessories that have not been previously classified under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cleared for marketing under a 510(k) submission, or approved in a PMA), as described in section 513(f)(6) of the FD&C Act. This updated guidance replaces the final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types,” issued on January 30, 2017. FDA’s Center for Devices and Radiological Health (CDRH) is also providing an additional resource on Device Advice, Medical Device Accessories, to summarize the regulation of accessories to medical devices. If you have any questions, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100. Thank you, Food and Drug Administration Center for Devices and Radiological Health