This draft guidance document provides the FDA’s recommendations on information to support premarket submissions for metallic coatings and/or calcium phosphate coatings on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.