part_subject: "PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT"
subpart_code: "A"
subpart_subject: "General"
section_number: "861.1"
section_subject: "Purpose and scope."
cfr_reference: "21 CFR 861.1"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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:
(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.