Allegations of Regulatory Misconduct Form
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: