Title 21

PART 803 SUBPART C

Subpart C - User Facility Reporting Requirements

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

21:8.0.1.1.3.3.1.1	SECTION 803.30	803.30 If I am a user facility, what reporting requirements apply to me
21:8.0.1.1.3.3.1.2	SECTION 803.32	803.32 If I am a user facility, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.3.1.3	SECTION 803.33	803.33 If I am a user facility, what must I include when I submit an annual report

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