FDA: Reporting Allegations of Regulatory Misconduct

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.