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2016-02-18
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Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
Rules and Regulations
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
81 FR 8146
https://www.govinfo.gov/app/details/FR-2016-02-18/2016-03331
2016-03331
fr18fe16-6
4164-01-P
Docket No. FDA-2011-N-0661
https://www.govinfo.gov/app/details/FR-2016-02-18/2016-03331
https://www.govinfo.gov/content/pkg/FR-2016-02-18/html/2016-03331.htm
https://www.govinfo.gov/content/pkg/FR-2016-02-18/pdf/2016-03331.pdf
Medical Devices
4 p.
8146
8149
81 FR 8146
Code of Federal Regulations
Title 21 Part 888
21 CFR Part 888
Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems; Federal Register Vol. 81, Issue
RULE
2016-03331
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-02-18
Docket No. FDA-2011-N-0661
4164-01-P
2016-03331
Final order.
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.
This order is effective on February 18, 2016.
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.
Medical Devices
Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
,
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdf
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM313605.pdf
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3780t1.rtf
http://www.regulations.gov
Federal Register
Vol. 81, no. 32
Office of the Federal Register, National Archives and Records Administration
2016-02-18
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-02-18
P0b002ee18e80d92f
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2016-02-18
https://www.govinfo.gov/content/pkg/FR-2016-02-18/pdf/FR-2016-02-18.pdf
https://www.govinfo.gov/content/pkg/FR-2016-02-18/xml/FR-2016-02-18.xml
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2016-02-18
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