Title 21

PART 860 SUBPART C

Subpart C - Reclassification

• 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
• 43 FR 32993, July 28, 1978, unless otherwise noted.

21:8.0.1.1.16.3.1.1	SECTION 860.120	860.120 General.
21:8.0.1.1.16.3.1.2	SECTION 860.123	860.123 Reclassification petition: Content and form.
21:8.0.1.1.16.3.1.3	SECTION 860.125	860.125 Consultation with panels.
21:8.0.1.1.16.3.1.4	SECTION 860.130	860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.5	SECTION 860.132	860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.6	SECTION 860.133	860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.7	SECTION 860.134	860.134 Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.8	SECTION 860.136	860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.

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