0910-AG78 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices 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. Economically Significant Previously Published in The Unified Agenda Completed Actions Yes No 21 CFR 888.3320 21 CFR 888.3330 21 USC 360e(b)(1) sec 515(b)(1) of the Federal Food, Drug, and Cosmetic Act ... No Withdrawn 11/30/2012 No State No No Michael Ryan 0910 Food and Drug Administration FDA 301 796-6283 michael.ryan@fda.hhs.gov White Oak, Building 66, Room 1615, 10903 New Hampshire Avenue, Silver Spring MD 20993