Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices." This draft guidance document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the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 This draft guidance is not final nor is it for implementation at this time.
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