EMERGO SUMMARY OF KEY POINTS:

• The US FDA’s new misconduct reporting tool allows anyone to file a complaint against a medical device manufacturer specifically for allegations of regulatory-related violations.
• Adverse event-related issues should continue to be reported to the FDA via its MedWatch website.

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has rolled out a new system through which allegations of regulatory conduct may be filed against medical device manufacturers.

Via email or standard mail, “anyone” may file such a complaint report pertaining to one or more of the following allegations:

• Failing to register and list a device with US authorities
• Marketing uncleared or unapproved devices
• Noncompliance with quality system requirements
• Misleading promotions or advertisements

Examples of regulatory misconduct provided by the CDRH include promoting a device for uses other than those for which the product has been cleared or approved; failing to submit required safety reports to the FDA; and registration document falsification.

What to include in allegation reports

The CDRH announcement recommends including information such as company name and contact details; device name and model; Unique Device Identifier (UDI); lot and/or serial number; and recall number.

Details regarding allegations along with any supporting documentation should also be included, according to the CDRH.

Misconduct reporting versus MedWatch

The new regulatory misconduct reporting tool is intended to target issues separate from serious adverse events, product quality problems or related topics for which the FDA’s MedWatch adverse event reporting website should be used.