Title 21

PART 862 SUBPART A

Subpart A - General Provisions

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 52 FR 16122, May 1, 1987, unless otherwise noted.

21:8.0.1.1.18.1.1.1	SECTION 862.1	862.1 Scope.
21:8.0.1.1.18.1.1.2	SECTION 862.2	862.2 Regulation of calibrators.
21:8.0.1.1.18.1.1.3	SECTION 862.3	862.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.18.1.1.4	SECTION 862.9	862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

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