Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

TJ Callahan; JB Gantenberg; BE Sands

doi:10.1520/STP25193S

SYMPOSIA PAPER Published: 01 January 1994

STP25193S

Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

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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.

Author Information

Callahan, TJ

Food and Drug Administration, Rockville, Maryland

Gantenberg, JB

Food and Drug Administration, Rockville, Maryland

Sands, BE

Food and Drug Administration, Rockville, Maryland

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Details

Developed by Committee: F04

Pages: 185–197

DOI: 10.1520/STP25193S

ISBN-EB: 978-0-8031-5266-3

ISBN-13: 978-0-8031-1854-6

Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

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