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HHS/FDA

RIN: 0910-AG78

Publication ID: 2012

Title: Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Abstract: The Food and Drug Administration 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: (1) hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, and (2) hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: Yes	Unfunded Mandates: No
CFR Citation: 21 CFR 888.3320    21 CFR 888.3330
Legal Authority: 21 USC 360e(b)(1)    sec 515(b)(1) of the Federal Food, Drug, and Cosmetic Act    ...

Legal Deadline:  None

Timetable: Action Date FR Cite Withdrawn  11/30/2012

Regulatory Flexibility Analysis Required: No	Government Levels Affected: State
Federalism: Yes
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Michael Ryan Regulatory Advisor Department of Health and Human Services Food and Drug Administration White Oak, Building 66, Room 1615, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6283 Email: michael.ryan@fda.hhs.gov