chapter  2
34 Pages

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.