Medical Devices; Effective Date of Requirement for Premarket Approval for Three Preamendment Class III Devices
Information
Type
Rule
Regulated products
Medical Devices
Published
April 13, 2000
Last updated
April 13, 2000
Description
Document number 00-9135. 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 following devices: The lung water monitor, the powered vaginal muscle stimulator, and the stair-climbing wheelchair. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)