The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices''. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. This draft guidance is not final nor is it in effect at this time.
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Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used ...
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81 FR 7543
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“Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (February 12, 2016), https://thefederalregister.org/documents/2016-02879/characterization-of-ultrahigh-molecular-weight-polyethylene-used-in-orthopedic-devices-draft-guidance-for-industry-and-f.