CFR›Title 21›Chapter I›Part 861 ContainsSubparts A–BCorpusDaily eCFRDisplayed edition2026-04-15Last updated2026-04-15 PART 861—PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT Subparts A Subpart A—General Sections 861.1–861.7 B Subpart B—Procedures for Performance Standards Development and Publication Sections 861.20–861.38 Authority21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264.Source45 FR 7484, Feb. 1, 1980, unless otherwise noted. Previous 860 Part 860—Medical Device Classification Procedures Next 862 Part 862—Clinical Chemistry and Clinical Toxicology Devices