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?

Standard No.
CFR 21-803.52-2013
Release Date
2013
Published By
US-CFR-file
Status
 2014-02
Replace By
CFR 21-803.52-2014
Latest
CFR 21-803.52-2014
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 FDA Form 3500A:

CFR 21-803.52-2013 history

  • 2014 CFR 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?
  • 2013 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?



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