Reporting Allegations of Regulatory Misconduct
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.