CFR 21-803.53-2014
Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.53:If I am a manufacturer, in which circumstances must I submit a 5-day report?

Standard No.

CFR 21-803.53-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-803.53-2014

Scope

You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b). These types of information correspond generally to the format of Form FDA 3500A:

CFR 21-803.53-2014 history

• 2014 CFR 21-803.53-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.53:If I am a manufacturer, in which circumstances must I submit a 5-day report?