GroundRules
21 CFR 812.45: Informing investigators.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
- Subpart C—Responsibilities of Sponsors
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON