Nineteen years after issuing final guidance on medical device reporting for manufacturers, the FDA has replaced that document with updated guidance providing new recommendations on reporting adverse events, requesting reporting exemptions, submitting five-day reports, and reporting remedial actions.
The guidance also makes two significant changes to draft guidance issued in July 2013. Specifically, it clarifies the draft’s recommendations on manufacturer reporting requirements when a device malfunction causes or contributes to a death or serious injury, and on requirements for manufacturer employees who learn of a reportable event.
The final guidance provides that adverse events for a device that is lawfully marketed in the United States and is being studied under an Investigational Device Exemption (IDE) are subject to reporting under both the IDE and MDR regulations.
Adverse events occurring outside the United States must be reported under the MDR regulation if the device, or a similar device in the case of malfunctions, is marketed in the United States.
In addition, the guidance describes the process for a contract manufacturer to request an exemption from MDR reporting. It also describes the process for a foreign manufacturer to request an exemption from MDR reporting to allow the importer to file a single report that will satisfy both manufacturer and importer reporting requirements.
Another update to the 1997 guidance discusses procedures for submitting five-day reports and reporting remedial actions.
In particular, it states that only events that require remedial actions to prevent an unreasonable risk of substantial harm to the public, or events for which FDA requests such a report, must be submitted as five-day reports. Other reportable adverse events should be submitted as 30-day reports.
Lastly, for a malfunction that is “likely to” cause or contribute to a death or serious injury, a firm should document whether the malfunction has actually led to deaths or serious injuries and can use this information to support a request for exemption from further reporting of the malfunction.
Kotz said the final guidance also clarifies two points from the March 2013 draft guidance.
First, the draft guidance states that if a malfunction caused or contributed to a death or serious injury, the manufacturer must report the original malfunction and all further occurrences of the malfunction for a period of two years, even if the malfunction did not cause or contribute to additional deaths or serious injuries.
By contrast, the final guidance allows a manufacturer to request an exemption from further reporting of the malfunction if recurrences have not contributed to further deaths or serious injuries and are unlikely to do so.
Second, the final guidance describes reporting requirements for manufacturer employees who become aware of an MDR-reportable event. The final guidance clarifies that anyone, including contractors or consultants that work for or on behalf of the manufacturer to review and process complaints, is considered to be an “employee” for the purposes of MDR reporting, and their roles should be defined in the company’s MDR procedure.