Title 21

PART 822 SUBPART G

Subpart G - Records and Reports

• 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
• 67 FR 38887, June 6, 2002, unless otherwise noted.

21:8.0.1.1.14.7.1.1	SECTION 822.31	822.31 What records am I required to keep
21:8.0.1.1.14.7.1.2	SECTION 822.32	822.32 What records are the investigators in my surveillance plan required to keep
21:8.0.1.1.14.7.1.3	SECTION 822.33	822.33 How long must we keep the records
21:8.0.1.1.14.7.1.4	SECTION 822.34	822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes
21:8.0.1.1.14.7.1.5	SECTION 822.35	822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan
21:8.0.1.1.14.7.1.6	SECTION 822.36	822.36 Can you inspect and copy the records related to my postmarket surveillance plan
21:8.0.1.1.14.7.1.7	SECTION 822.37	822.37 Under what circumstances would you inspect records identifying subjects
21:8.0.1.1.14.7.1.8	SECTION 822.38	822.38 What reports must I submit to you

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