U.S. FDA plans to let device makers report malfunctions less frequently



(Reuters) – The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.

The FDA said in a statement that it is proposing to allow the manufacturers to report certain malfunctions in summary reports, rather than having to file individual reports for each malfunction. They would still be required to file individual reports for deaths and serious injuries, the agency said.

It has not yet finalized which devices it will allow to file these quarterly reports, but said that new types of medical devices will not be eligible for at least two years.

The regulator is seeking comments about the proposed policy change for 60 days.

Reporting by Michael Erman in New York and Manas Mishra in Bengaluru; editing by Grant McCool

Our Standards:The Thomson Reuters Trust Principles.


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