Title 21

PART 864 SUBPART A

Subpart A - General Provisions

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

21:8.0.1.1.19.1.1.1	SECTION 864.1	864.1 Scope.
21:8.0.1.1.19.1.1.2	SECTION 864.3	864.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.19.1.1.3	SECTION 864.9	864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

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