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.
Medical Device Manufacturers: What are the implications?
So, what will come of these submitted allegations? Should we expect an influx of 483’s and inspections? Perhaps, but not blindly administered simply based on an allegation.
Any allegations submitted will be prioritized by level of potential risk, and then be reviewed by the Center for Devices and Radiological Health (CDRH). CDRH will further investigate claims if necessary. Depending on the outcome of the investigation, responses may vary and could range from ongoing monitoring, to an inspection, or the issuance of a 483.
How should medical device manufacturers respond to this new guidance? For those confident in their regulatory and quality systems, this portal should not create undue duress.
If a claim is brought, a thorough compliance program will likely ease any concerns of the FDA. If there are internal concerns about a lax quality system, this may be a good time to revisit and reinforce those areas of your business.
Note: This communication is for informational purposes only. Although every reasonable effort is made to present current and accurate information, Oswald makes no guarantees of any kind and cannot be held liable for any outdated or incorrect information.