CFR 21-803.52-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?
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 FDA Form 3500A:
CFR 21-803.52-2013 history
2014CFR 21-803.52-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?
2013CFR 21-803.52-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?