FDA Clarifies Pathways for Medical Device Accessories

For the third time in under a year, 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.

The December 2017 guidance clarifies that the de novo classification process is not the only mechanism available for classifying a new accessory type. The FDA had previously encouraged device manufacturers to use the de novo classification process for new types of accessories that had not been previously classified.