Zdrowie i gospodarka · 30/07/1998

FDA Proposes New Requirements for Certain Class III Medical Devices

The US Food and Drug Administration (FDA) is proposing to require premarket approval for three high-priority Group 3 Class III medical devices, including microwave diathermy, ultrasonic diathermy, and ultrasound and muscle stimulator devices, for uses other than treating select medical conditions such as pain, muscle spasms, and joint contractures.