The Food and Drug Administration has published a draft guidance for its regulation of medical device accessories. Public comments may be submitted at any time but are encouraged by April 20, 2015. Online comments may be submitted to the general federal government regulatory comment website, and referencing Docket No. FDA–2015–D–0025.
Under the Federal Food, Drug, and Comestic Act, a “device” means “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is….intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease… ”
The guidance defines a “parent device” as “a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories” and defines a “device accessory” as “a device that is intended to support, supplement, and/or augment the performance of one or more parent devices”.
Instead of always classifying a device accessory the same way as its parent device, this draft guidance proposes that there be specific classifications for new types of devices that may have independent uses separate from their parent devices. The FDA would then make a specific risk analysis about the safety and effectiveness of the new type of accessory device. This proposal has specific implications for emerging health information technologies that are intended to have diagnostic or treatment functions.
Here is the request for comments published in the Federal Register: