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Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

Source

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