New Draft Guidance from FDA!! Do you work in the orthopedic devices space and would like to have a better handle on the submission requirements for devices with metallic and phosphate coatings? Look no further! On January 23, 2024, the Federal Register announced a request for comment on the draft guidance document Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices issued on January 23, 2024. When final, the guidance will supersede 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, date March 10, 1995 (revised February 20, 1997) and Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements dated February 2, 2000. Coating variability affects physical and mechanical properties and hence the safety of the device. This guidance provides submission and change assessment recommendations for class II and III coated orthopedic devices.
FDA will accept electronic or written comments on the draft guidance until March 22, 2024. Now is the time to influence the guidance document language!
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