Medical Device Violations: FDA Launches Portal to Report Regulatory Misconduct

Author: Heather Maver – December 7th, 2016

The FDA recently launched a portal for individuals to report allegations of regulatory misconduct of a medical device manufacturer or individuals marketing a medical device. An allegation in this manner is any claim that a medical device manufacturer may be operating in a manner that violates the law and circumvents the FDA’s ability to monitor activity for the safety of patients.

This process was established to help the FDA identify potential risks to patients. It is possible for companies to operate under the radar of the FDA, or import devices that do not meet legal requirements for admission to the U.S. This allegation portal will aid in correcting potential violations.

While the portal and FDA guidance encourages those submitting information to provide contact information in the event additional information is needed, a complaint can be submitted anonymously. Complaints can be submitted via the online form, found here, via mail, or email.

The types of allegations that may be reported could be the failure to register a medical device, marketing of devices that have not been cleared or approved by the FDA, or misleading promotion of a device. Additional examples of allegations can be found on the FDA’s site fully detailing the program.



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