FDA Streamlines Device Malfunction Reporting

As part of its effort to streamline the process for reporting malfunctioning medical devices, the U.S. Food and Drug Administration (FDA) has finalized a new program that will allow quarterly reporting of malfunctions on a selected basis.

In a press release issued by the FDA, the agency says that it has finalized the terms of its Voluntary Malfunction Summary Reporting Program. Under the Program, manufacturers of medical devices with eligible product codes will be allowed to submit certain device malfunction medical device reports (MDRs) on a quarterly basis and in summary form.

The FDA says that the Program is expected to significantly reduce the number of reports that those manufacturers will be required to submit to the agency, while still providing the FDA with sufficient information to monitor the safety of medical devices on the market. The FDA also says that the new approach to malfunction reporting may also make it easier for the general public to understand related medical device malfunctions, since they will be grouped together in the summary reports.

The FDA notes that only manufacturers of medical devices bearing product codes that have existed for at least two years are potentially eligible to participate in the Program.

Read the complete text of the FDA’s press release on the Voluntary Malfunction Summary Reporting Program.


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