The US FDA plans to allow device manufacturers to report defects less frequently

(Reuters) – The U.S. Food and Drug Administration said on Friday it plans to allow medical device makers to report quarterly less serious defects in some devices to reduce the need for repeated reviews of common problems.

In a statement, the FDA said it was proposing to allow manufacturers to report specific defects in summary reports rather than having to produce individual reports for each failure. The agency said they would still be required to submit individual reports on deaths and serious injuries.

It has not yet determined which devices it will allow for quarterly reporting, but said new types of medical devices will not be eligible for at least two years.

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

(Reporting by Michael Erman in New York and Manas Mishra in Bengaluru; Editing by Grant McCool)