1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
  6. Subpart C - Responsibilities of Sponsors
  7. 21 CFR § 812.45
21 CFR § 812.45
Informing investigators
June 25, 2020
CFR

A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device.

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§ 812.43 Selecting investigators and monitors
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§ 812.46 Monitoring investigations

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