October 27, 2016 Practice Points

FDA Rolls Out Site for Medical Device Violation Reporting

The Center for Devices and Radiological Health will review any allegations and decide if investigation and further enforcement action is warranted.

By Eric W. Shannon

The Food and Drug Administration (FDA) recently unveiled a new portal on its website allowing anyone to report allegations that a medical-device manufacturer or medical-device marketer is violating the law, as reported by Law360. The portal, called “Reporting Allegations of Regulatory Misconduct,” went live on the agency website on October 21, 2016. Examples of conduct meriting disclosure, per the FDA, include:

  • a third party’s forgery of an export certificate to bring devices into the country;
  • a company’s promotion or advertising of a device outside the FDA-cleared or approved indications for use;
  • a company’s failure to register and list its medical devices with the FDA; and
  • a manufacturer’s knowing deceit of the FDA.

“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 on the site. While the FDA encourages those submitting allegations of wrongdoing to include “supporting information in case additional information is needed for the FDA to understand . . . and act on the report,” visitors can choose to submit complaints anonymously, per the website.

Per the FDA, the Center for Devices and Radiological Health will review the allegations and decide if investigation and further enforcement action is warranted.

 

Eric W. Shannon is an associate with Debevoise & Plimpton LLP in New York, New York.


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