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Medical Devices / Regulatory Affairs / Postmarket Safety / Submissions and Approvals

CDRH Proposes New Medical Device Malfunction Reporting Program

Jan. 3, 2018

CDRH is proposing a new industry program for reporting certain medical device malfunctions.

The new voluntary program is intended to “streamline this process through a summary reporting system that would enable us to more efficiently detect potential safety issues and free up agency resources to better focus on addressing them,” said CDRH Director Jeff Shuren.

While manufacturers must report certain device malfunctions to the FDA, individual reports often “describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” Shuren said.

The standard industry MDR reporting requirements for deaths and serious injuries associated with devices will remain unchanged, the agency said.

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