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GUIDANCE DOCUMENT

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices Draft Guidance for Industry and Food and Drug Administration Staff January 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-5430

Docket Number:
FDA-2023-D-5430
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on information to support premarket submissions for metallic coatings and/or calcium phosphate coatings on orthopedic devices. This guidance applies to metallic coatings, calcium phosphate coatings, or metallic and calcium phosphate dual coatings on orthopedic devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for orthopedic devices which contain metallic and/or calcium phosphate coatings.

 
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