Question of the Month with Comment
MedSun: Newsletter #1, February 2006

Question: Does MAUDE include reports about investigational devices?

Comment: MAUDE does not serve as the repository for reports about investigational devices involved in research protocols, however sometimes reports of this type are submitted by mistake. If the study is being conducted in the U.S. under the investigational device exemption (IDE), then the manufacturer sends adverse event reports to FDA as part of a supplement to the IDE. For more information about Investigational Device Exemptions (Code of Federal Regulations: 21CFR812.150), see Additional Information below.

Additional Information:

For more information about Investigational Device Exemptions (Code of Federal Regulations: 21CFR812.150) go to:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.150


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