Title 21

PART 814 SUBPART C

Subpart C - FDA Action on a PMA

• 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.

21:8.0.1.1.11.3.1.1	SECTION 814.40	814.40 Time frames for reviewing a PMA.
21:8.0.1.1.11.3.1.2	SECTION 814.42	814.42 Filing a PMA.
21:8.0.1.1.11.3.1.3	SECTION 814.44	814.44 Procedures for review of a PMA.
21:8.0.1.1.11.3.1.4	SECTION 814.45	814.45 Denial of approval of a PMA.
21:8.0.1.1.11.3.1.5	SECTION 814.46	814.46 Withdrawal of approval of a PMA.
21:8.0.1.1.11.3.1.6	SECTION 814.47	814.47 Temporary suspension of approval of a PMA.

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