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# Draft Guide on Orthopedic Device Coatings
- URL: https://www.fdaweb.com/draft-guide-on-orthopedic-device-coatings/
- Published: 2024-01-22T12:00:00.000Z
- Updated: 2026-09-14T14:20:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156177

FDA has released a [draft guidance](https://www.fda.gov/media/175564/download?ref=fdaweb.com) entitled “Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.” The document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings or calcium phosphate coatings on the surface. They are intended to reflect current review practices and are intended to promote consistency and facilitate efficient submission reviews, the agency says.

The guidance says its recommendations address the characterization of a metallic coating, which can be manufactured using thermal spray (e.g., plasma spray), sintering (e.g., sintering of powders, beads, or fiber mesh pad), chemical vapor deposition/infiltration, physical vapor deposition (e.g., ionic plasma deposition), additive manufacturing (e.g., electron beam manufacturing, selective laser sintering) or other methods. It also addresses calcium phosphate coatings, which can be manufactured by plasma spray, solution precipitation, electrochemical deposition or other methods; and metallic and calcium phosphate dual coatings, which can be manufactured using one or more of the above methods.