Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
fda-device · Food and Drug Administration · Rule · Published 2016-02-18 · Effective 2016-02-18 · 81 FR 8146
Document
Document number
2016-03331
Federal Register citation
81 FR 8146
CFR reference
21 CFR 888
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-02-18
Effective date
2016-02-18
HHS docket
Docket No. FDA-2011-N-0661
Abstract
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.