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WHAT:  FDA reporting  of allegation of regulatory misconduct of medical device manufacturer or individuals marketing medical devices

WHY: Help FDA identify potential risks to patients, determine whether further investigation is warranted, and identify steps needed to address or correct violation

WHO: Anyone may file a complaint; identity or contact information will not be shared publicly

 

HOW: Allegations of Regulatory Misconduct Form, by email, or by regular mail.

LEARN

 

 


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