Regulatory Misconduct: FDA Launches Website for Allegations Against Device Manufacturers
Posted 24 October 2016 | By
A little more than a week after a scathing report in the Minneapolis Star-Tribune revealed the US Food and Drug Administration (FDA) has accepted late adverse event reports from device companies for hundreds of thousands of incidents, and the agency on Monday launched a new website for regulatory misconduct allegations.
The webpage, Allegations of Regulatory Misconduct, allows anyone to submit a claim (via a new, simplified online form) if it is believed that a medical device manufacturer or individuals marketing devices may be doing so in a manner that violates the law.
“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,” the agency said in a statement.
According to the new site, examples of allegations that can be submitted include:
- Promotion or advertising of a device outside FDA’s 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.
- A device is being marketed without the appropriate FDA clearance (510(k)) or approval (PMA) application.
- A manufacturer imports medical devices into the US that do not meet legal requirements.
- A third party outside a device company forges or falsifies an export certificate to bring devices into the US.
- A company fails to register and list their devices with FDA, thus preventing the agency from having the required information about a marketed device.
- A manufacturer knowingly deceives FDA (ie. the manufacturer hides information or falsifies documents).
“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,” the agency says.
Allegations of regulatory misconduct related to medical devices are reviewed by the Center for Devices and Radiological Health (CDRH) and prioritized based on the level of potential risks to patients. If a new risk is identified, CDRH may send a warning letter to the device firm, conduct an inspection at the manufacturing facility or request a device recall.
FDA also says it will monitor the allegations using additional sources of reported information (e.g. medical device reports, new complaints and inspection reports) to determine necessary actions.
The agency also points to its webpage outlining how to obtain records via the Freedom of Information Act, which is how the Star-Tribune was able to craft its news story.