e codified annually in the Code of Federal Regulations (CFR).
             The definition of a device appears in section 201(h) of the FD&C Act. A device is:
             "...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 in the official National Formulary, or the United States Pharmacopeia, or any supplement to them
             ...