Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff

Name: Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff
Creator: Food and Drug Administration
Keywords: fda,guidances,implants,industry,orthopedic,pms,post-market,post-market-surveillance,requirements,support,surveillance,testing

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Postmarket

Published

February 1, 2000

Last updated

March 18, 2020

Description

This document provides guidance on testing metallic plasma sprayed coatings on orthopedic implants for postmarket surveillance requirements.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff

Updated on March 18, 2020

pdf (38.0KB)

URL: https://www.fda.gov/media/74184/download
Permalink: https://data.openrid.co/en/datasets/r/38a91584-27ad-4885-90eb-57b9ce9d739a
MIME Type: application/pdf

Created on: February 1, 2000
Modified on: March 18, 2020

Size: 38.0KB

Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

License

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