Title 21

PART 803 SUBPART E

Subpart E - Manufacturer Reporting Requirements

• 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
• 79 FR 8846, Feb. 14, 2014, unless otherwise noted.

21:8.0.1.1.3.5.1.1	SECTION 803.50	803.50 If I am a manufacturer, what reporting requirements apply to me
21:8.0.1.1.3.5.1.2	SECTION 803.52	803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.5.1.3	SECTION 803.53	803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report
21:8.0.1.1.3.5.1.4	SECTION 803.56	803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports
21:8.0.1.1.3.5.1.5	SECTION 803.58	803.58 Foreign manufacturers.

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