Devices

FDA Urges Public to Report Device Regulatory Misconduct

FDA is urging the public and industry insiders to report regulatory misconduct against medical device manufacturers or individuals marketing medical devices who may be violating the law. Reporting these allegations “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,” an agency notice says. “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,” it says.

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 promotions. Examples for misconduct include:

Promotion or advertising of a device outside the FDA-cleared or approved indications for use.
Failure 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 PMA approval.
A manufacturer imports medical devices into the U.S. that do not meet legal requirements for admission.
A third party outside a 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 FDA by hiding information or falsifying documents.

Allegations can be submitted through the Web page: Allegations of Regulatory Misconduct Form, by email (OCMedicalDeviceCo@fda.hhs.gov), and regular mail:

Attention: Allegations of Regulatory Misconduct Branch
Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
WO Bldg. 66 RM 3523

Allegations of regulatory misconduct related to medical devices will be reviewed by CDRH. They will be prioritized based on the level of potential risks to patients.

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