CFR 21-803.32-2014
Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?

Standard No.

CFR 21-803.32-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-803.32-2014

Scope

You must include the following information in your report, if reasonably known to you, as described in § 803.30(b). These types of information correspond generally to the elements of Form FDA 3500A:

CFR 21-803.32-2014 history

• 2014 CFR 21-803.32-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?
• 2013 CFR 21-803.32-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?