CFR 21-803.16-2014
Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.16:When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?

Standard No.

CFR 21-803.16-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-803.16-2014

Scope

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 d

CFR 21-803.16-2014 history

• 2014 CFR 21-803.16-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.16:When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?