SEDL / STP / STP1196-EB / STP25193S

Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants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

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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.