Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the 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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 888 [Docket No. FDA-2011-N-0661] AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the 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. DATES: This order is effective on February 18, 2016. FOR FURTHER INFORMATION CONTACT: Sergio M. de del Castillo, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-796-6419. SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 ( Pub. L. 105-115 ), the Medical Device User Fee and Modernization Act of 2002 ( Pub. L. 107-250 ), the Medical Devices Technical Corrections Act ( Pub. L. 108-214 ), the Food and Drug Administration Amendments Act of 2007 ( Pub. L. 110-85 ), and the Food and Drug Administration Safety and Innovation Act (FDASIA) ( Pub. L. 112-144 ), among ot…
Other Federal Register documents from the same docket.
Citation: 81 FR 8146
