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# Orthopedic Device Coatings Guidance
- URL: https://www.fdaweb.com/orthopedic-device-coatings-guidance/
- Published: 2024-01-23T12:00:00.000Z
- Updated: 2026-09-14T14:20:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156196

FDA has published a draft guidance, *Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices*, with recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/characterization-metallic-coatings-andor-calcium-phosphate-coatings-orthopedic-devices?ref=fdaweb.com) says the recommendations reflect current review practices and are intended to promote consistency and facilitate the efficient review of submissions.

The recommendations in the guidance are applicable to Class 2 and 3 devices that contain metallic and/or calcium phosphate coatings, intended for orthopedic applications, FDA says. Other types of coatings are not within its scope.