Almost two years after issuing draft guidance on how it classifies accessory devices, the FDA has released the final guidance that also clarifies when software as a medical device is an accessory.
The final guidance defines “accessory” as “a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” The guidance also encourages manufacturers to use the de novo classification process to request classification of accessories that have not been previously classified, cleared or approved.
The final guidance updates the Jan. 20, 2015 draft guidance to apply it to all software products that meet the definition of an accessory, including software as a medical device (SaMD).
SaMD that uses data from a medical device does not automatically become an accessory. For example, a stand-alone software program intended to analyze radiological images or data generated by a device is considered SaMD but not an accessory.