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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 |
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Timetable:
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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 |