FDA: Reporting Allegations of Regulatory Misconduct

The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously. The FDA will not share your identity or contact information with anyone outside the FDA unless required to do so by law, regulation, or court order. FDA
US Food and Drug Administration

What kinds of allegations can be reported?

Allegations of regulatory misconduct may include failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow quality system requirements, or misleading promotion. The table below provides some examples of the kind of allegations the FDA has received:

Examples of allegations
  • Promotion or advertising of a device outside the FDA-cleared or approved indications for use.
  • A device manufacturer fails to submit required reports to the FDA for device-related safety concerns, and/or is not conducting required follow up investigations per the regulatory requirements.
  • A company’s medical devices or manufacturing processes do not meet their design and manufacturing responsibilities.
  • Marketing a medical device without the appropriate FDA clearance (510(k)) or approval (PMA).
  • A manufacturer imports medical devices into the United States that do not meet legal requirements for admission to the U.S.
  • A third party outside the medical device company forges or falsifies an export certificate to bring medical devices into the U.S.
  • A company fails to register and list their medical device products with the FDA, preventing the FDA from having required information about a device on the market.
  • A manufacturer knowingly deceives the FDA. For example, the manufacturer hides information from the FDA, or falsifies documents, etc. given to the FDA.
Allegations of Regulatory Misconduct Branch
Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
WO Bldg. 66 RM 3523
10903 New Hampshire Ave
Silver Spring, MD 20993

COVID-19
news

stay connected

don’t miss any news of the
Implant-Register,
tailored to your preferences

                                  GET IT!

Scroll to Top