FDA Issues PMA/PDP Filing Rules for Three Devices

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval (PMA) application or a notice of completion of product development protocol (PDP) for three high-priority Group 3 preamendments Class III medical devices. The devices are: the microwave diathermy device for uses other than treatment of select medical conditions, such as relief of pain, muscle spasms, and joint contractures; the ultrasonic diathermy device for uses other than treatment of select medical conditions, such as relief of pain, muscle spasms, and joint contractures; and the ultrasound and muscle stimulator device for uses other than treatment of select medical conditions, such as relief of pain, muscle spasms, and joint contractures. The uses of these three devices do not include use for the treatment of malignancies.

The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices.

The effective date of the final rule is April 14. For more information, contact Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850. Tel: 301-594-1184.