CFR›Title 21›Chapter I›Part 821 ContainsSubparts A–DCorpusDaily eCFRDisplayed edition2026-04-23Last updated2026-04-23 PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS Subparts A Subpart A—General Provisions Sections 821.1–821.4 B Subpart B—Tracking Requirements Sections 821.20–821.25 C Subpart C—Additional Requirements and Responsibilities Section 821.30 D Subpart D—Records and Inspections Sections 821.50–821.60 Authority21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.Source58 FR 43447, Aug. 16, 1993, unless otherwise noted. Previous 820 Part 820—Quality Management System Regulation Next 822 Part 822—Postmarket Surveillance