Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

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Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants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

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

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

Pages: 13 Published: Jan 1994

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Source: STP1196-EB

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FDA draft guidance, calcium phosphate coatings, labeling claims, test methods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