Table 8.

Congressional Definition of a “Custom Device”

•Is created or modified in order to comply with the order of an individual physician or dentist (or other specially qualified person)

•Necessarily deviates from an otherwise applicable performance standard under section 514 or section 515 of the FDCA

•Is not generally available in the United States in finished form through labelling or advertising by the manufacturer, importer, or distributor for commercial distribution

•Is designed to treat an unique pathology or physiological condition that no other device is domestically available to treat

•Is either a) intended to meet the special needs of such physician or dentist in the course of professional practice of such physician or dentist, or b) is intended for use by an individual patient named in the order of a physician or dentist (or other specially qualified person as designated)

•Is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals, physician, or dentist

•May have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices

FDCA = Food, Drug and Cosmetics Act.