Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
Information
Type
Proposed Rule
Regulated products
Published
August 25, 2010
Last updated
August 25, 2010
Description
Document number 2010-21142. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following four class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; female condom; and transilluminator for breast evaluation. The agency is also summarizing its proposed 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. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)