Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

As discussed in Chapter 1, in the United States (according to 201(h) of the Food, Drug and Cosmetic Act), a medical device is dened as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, that is both:

• Recognized in the ofcial National Formulary, the United States Pharmacopoeia (USP), or any supplement to them.