Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices." This draft guidance document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface. This draft guidance is not final nor is it for implementation at this time.
Abstract as published in the Federal Register.
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