Zdrowie i gospodarka · 13/04/2000

FDA Issues Final Rule for Three Class III Devices Requiring Premarket Approval

The Food and Drug Administration (FDA) is issuing a final rule to retain three class III preamendment devices in class III and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the lung water monitor, powered vaginal muscle stimulator, and stair-climbing wheelchair. The FDA has evaluated the risks and benefits of these devices to determine if they meet the agency's approval requirements.