federal_register: 99-4213
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 99-4213 | Draft Guidance for Industry on Testing Orthopedic Implants With Metallic Plasma Sprayed Coatings to Support Reconsideration of Postmarket Surveillance Requirements; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry on Testing Orthopedic Implants With Metallic Plasma Sprayed Coatings to Support Reconsideration of Postmarket Surveillance Requirements.'' This draft guidance is neither final nor is it in effect at this time. Metallic plasma spray coatings, both porous and nonporous, and metallic sintered or diffusion bonded porous coatings are used to attach artificial joints to living bone. FDA's Center for Devices and Radiological Health (CDRH) is identifying a set of testing methods that will accurately compare the mechanical properties of metallic plasma spray coatings with the same properties of sintered or diffusion bonded porous coatings. This draft guidance document proposes to use a number of mechanical tests to compare the mechanical properties of the various types of coatings. CDRH needs the ability to make the above comparisons in order to identify coated hip devices that should be subject to postmarket surveillance requirements. | 1999-02-22 | 1999 | 2 | https://www.federalregister.gov/documents/1999/02/22/99-4213/draft-guidance-for-industry-on-testing-orthopedic-implants-with-metallic-plasma-sprayed-coatings-to | https://www.govinfo.gov/content/pkg/FR-1999-02-22/pdf/99-4213.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry on Testing Orthopedic Implants With Metallic Plasma Sprayed Coatings to Support Reconsideration of Postmarket Surveillance... |