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"Stay updated on FDA s proposed guidance for orthopedic product coatings. Learn about additional data requirements and potential changes to 510(k) submissions."

Draft guidanceRemarket application requirementsRthopedic product coatingsRegulatory focusAlcium phosphate coatingCoating processTerility considerationsIocompatibility considerationsSpecial controlConsensus standardsDa recognized versionPublic healthDeclaration of