Today the FDA launched a webpage on Allegations of Regulatory Misconduct, which are claims that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. The website explains the process for submitting allegations to the Center for Devices and Radiological Health (CDRH) and contains a form to simplify the submission process .
Reporting allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation.
If you have questions about submitting an allegation, you may contact the Allegations of Regulatory Misconduct Staff by phone at (240) 402-7675 or by email at OCMedicalDeviceCo@fda.hhs.gov.
Food and Drug Administration
Center for Devices and Radiological Health