Purpose and scope.

§ 861.1 Purpose and scope. (a) This part implements section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment, amendment, and revocation of performance standards applicable to devices intended for human use. (b) The Food and Drug Administration may determine that a performance standard, as described under special controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance of the safety and effectiveness of the device. Performance standards may be established for: (1) A class II device; (2) A class III device which, upon the effective date of the standard, is reclassified into class II; and (3) A class III device, as a condition to premarket approval under section 515 of the act, to reduce or eliminate a risk or risks associated with such device. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. [45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 FR 58404, Dec. 10, 1992]