Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices

This ICR collects information voluntarily submitted to the Center for Devices and Radiological Health (CDRH) on s allegations of regulatory misconduct associated with medical devices. Allegations may be related to the sale of unapproved or uncleared medical devices, false claims, or inappropriate advertising. Because there has been no established guidelines or instructions on how to submit allegations of misconduct to CDRH, such allegations often contain minimal information and are received via phone calls, emails, or conversationally from any CDRH staff. CDRH seeks to establish a consistent format and process for the submission of allegations of regulatory misconduct that will enhance our timeliness in receiving, assessing and evaluating this voluntary information. The information provided in the allegations received by CDRH may be used to clarify the recurrence or emergence of significant device-related risks to the general public and the need to initiate educational outreach or regulatory action to minimize or mitigate identified risks.

The latest form for Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices expires 2023-11-30 and can be found here.