Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices
Information
Type
Rule
Regulated products
Published
August 16, 2011
Last updated
August 16, 2011
Description
Document number 2011-20664. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. 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. This action implements certain statutory requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)