More Medical Devices Exempt From FDA Notification

The FDA Aug. 13 added eight product codes to the list of medical devices exempt from 510(k) premarket notification requirements.

The move adds to the 120 device product codes the Food and Drug exempted from 510(k) premarket clearance requirements on July 1 7 HITR 6, 7/13/15, 9 LSLR 802, 7/10/15, 9 MELR 421, 7/8/15.

A guidance document dated Aug. 14 incorporates the eight additional product codes the agency intends to exempt from the requirements, updating a July 1 guidance that outlined the agency’s plans to exempt the 120 product codes.

Device product codes identified in Section IV of the ...