CFR›Title 21›Chapter I›21 CFR Part 807 Citation21 CFR Part 807ContainsSubparts Subpart A–Subpart ECorpusDaily eCFRDisplayed edition2026-09-03Last updated2026-09-03 PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Subparts Subpart A Subpart A—General Provisions Subpart B Subpart B—Procedures for Device Establishments Subpart C Subpart C—Procedures for Foreign Device Establishments Subpart D Subpart D—Exemptions Subpart E Subpart E—Premarket Notification Procedures Authority21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.Source42 FR 42526, Aug. 23, 1977, unless otherwise noted.
PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES