Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Information
Type
Proposed Rule
Regulated products
Published
January 18, 2013
Last updated
January 18, 2013
Description
Document number 2013-01006. 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 two class III preamendments devices: Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. 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)