STP1196: Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

    Callahan, TJ
    Associate Director, Food and Drug Administration, Rockville, Maryland

    Gantenberg, JB
    Scientific Reviewer, Food and Drug Administration, Rockville, Maryland

    Sands, BE
    Scientific Reviewer, Food and Drug Administration, Rockville, Maryland

    Pages: 13    Published: Jan 1994


    Abstract

    The interest and use of calcium phosphate materials as medical device coatings prompted the FDA to draft a guidance document that would aid the characterization of these materials. The document is intended to inform medical device manufacturers of important information that should be provided to the FDA in submissions on Orthopedic and Dental products.

    Keywords:

    FDA draft guidance, calcium phosphate coatings, labeling claims, test methods


    Paper ID: STP25193S

    Committee/Subcommittee: F04.03

    DOI: 10.1520/STP25193S


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