On January 20, 2015, FDA released a draft guidance defining a medical device accessory and outlining a new framework for classifying and approving accessories.  The guidance 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."

FDA has traditionally classified accessories in the same class as the parent device, or by issuing a separate classification regulation.  In the new guidance, FDA indicated that it would access the risk of accessories according to their use with the parent devices, and that "the risk profile of an accessory can differ significantly from that of the parent device, warranting differences in regulatory classification." 

The guidance further recommends that manufacturers consider submitting de novo classification petitions for device accessories, which would allow  the products to be brought to market more quickly.  Please contact Matt Daly, Compliance Specialist, if you would like more information on this topic.

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