as a subclass of medical devices and establish accessories as medical devices.

Definitions by region

United States (Food and Drug Administration)

Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
* recognized

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