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  1. Medical Device Safety

Allegations of Regulatory Misconduct Form

Allegations of Regulatory Misconduct Form

OMB control number: 0910-0769
Approval Expiration Date: 11/30/2020

This form is to report an allegation of regulatory misconduct, a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. Submitting an allegation is voluntary, and the form does not have to be complete in order for the allegation to be reviewed.

Please include as much of the following information as possible to help the FDA assess the allegation you are reporting:




 

Please email any document attachments to CDRHDeviceAllegations@fda.hhs.gov. Please send attachments from your email address used above.