Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: January 23, 2024
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Orthopedic
Status: Draft

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance document provides the FDA’s recommendations on information to support premarket submissions for metallic coatings and/or calcium phosphate coatings on orthopedic devices. This guidance applies to metallic coatings, calcium phosphate coatings, or metallic and calcium phosphate dual coatings on orthopedic devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for orthopedic devices which contain metallic and/or calcium phosphate coatings.

Download the Guidance Document