FDA’s 60-Day Extension For Medical Device Defects Not Likely Obstructive To Public Health

Under a new deal between the U.S. Food and Drug Administration and the medtech device industry, manufacturers would be required to report device defects within three months of detecting their potential threat of injury ? a tripling of the current 30-day reporting period.

Events requiring recall or immediate action to prevent public harm would still be regulated under a current five-day range, according to the New York Times.

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