FDA updates Class II medical devices exempt from premarket notification

Editor's Note

The Food and Drug Administration (FDA) on July 11 announced a list of 1,003 Class II devices that the Agency says no longer require premarket notification to provide reasonable assurance of safety and effectiveness.

The exemptions were made in an effort to decrease regulatory burdens on the medical device industry and to eliminate private costs and expenditures required to comply with Federal regulations.

In addition, device labelers who have submitted device identifier records to the Global Unique Device Identification Database for devices that are now exempt or partially exempt from premarket notification requirements may need to make changes to these records in the future.

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is...