Daily eCFR

Part 4—Regulation of Combination Products

21 CFR Part 4

Citation21 CFR Part 4

ContainsSubparts Subpart A–Subpart B

CorpusDaily eCFR

Displayed edition2026-08-04

Last updated2026-08-04

PART 4—REGULATION OF COMBINATION PRODUCTS

Subparts

Subpart A
Subpart A—Current Good Manufacturing Practice Requirements for Combination Products
Subpart B
Subpart B—Postmarketing Safety Reporting for Combination Products

Authority21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

Source78 FR 4321, Jan. 22, 2013, unless otherwise noted.