On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015) (“Draft Accessory Guidance”). The Draft Accessory Guidance provides FDA’s proposed definition of an accessory and explains the agency’s process and proposal for classifying medical device accessories. Comments on the draft guidance may be submitted to www.regulations.gov until April 20, 2015 and should reference docket number FDA-2015-D-0025-0001.

What is an Accessory?

In the draft guidance, FDA defines an accessory as “a device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” A parent device is defined as “a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.”3 FDA further explains that determination of whether a product is intended for use with one or more parent devices will be based on the labeling and promotional materials of the product (i.e., the potential accessory) rather than the labeling and promotional materials of the parent device.