FDA Clarifies Pathways for Medical Device Accessories

The FDA issued a final guidance on medical device accessories, clarifying that a New Accessory Request can be included as part of a PMA, PMA supplement or a 510(k) submission.

In the updated guidance, the agency said the request should be submitted together with the parent device submission and should include a cover letter that clearly identifies that the submission includes a New Accessory Request.

If an accessory request included in a cleared or approved premarket submission is denied, the new accessory type “may be legally marketed but will be considered to be in the same classification as the parent device,” the agency said.