Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

Notes

^KK The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

^LL The IEC 60601-1 international standard for medical electrical equipment indicates that medical electrical equipment includes those accessories that are necessary to enable the normal use of the equipment which includes facilitation of its use.

^MM These two lifting methods would be viewed as equivalent.

^NN It is important to note that the ADA concept of “equivalent facilitation” and the FDA concept of “substantial equivalence” are not identical or interchangeable.

^OO It is extremely unlikely that modifying any imaging equipment to make it accessible would trigger a premarket approval process.