GroundRules
21 CFR 803.16: When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
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 803—MEDICAL DEVICE REPORTING
- Subpart A—General Provisions
No. A report or other information submitted by you, and our release of that report or information, is not necessarily an admission that the device, or you or your employees, caused or contributed to the reportable event. You do not have to admit and may deny that the report or information submitted under this part constitutes an admission that the device, you, or your employees, caused or contributed to a reportable event.
Collected 2026-08-27T02:24:47Z. Source file · JSON