Title 21

PART 814 SUBPART A

Subpart A - General

• 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
• 51 FR 26364, July 22, 1986, unless otherwise noted.

21:8.0.1.1.11.1.1.1	SECTION 814.1	814.1 Scope.
21:8.0.1.1.11.1.1.2	SECTION 814.2	814.2 Purpose.
21:8.0.1.1.11.1.1.3	SECTION 814.3	814.3 Definitions.
21:8.0.1.1.11.1.1.4	SECTION 814.9	814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
21:8.0.1.1.11.1.1.5	SECTION 814.15	814.15 Research conducted outside the United States.
21:8.0.1.1.11.1.1.6	SECTION 814.17	814.17 Service of orders.
21:8.0.1.1.11.1.1.7	SECTION 814.19	814.19 Product development protocol (PDP).

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