The following new items were added to the CDRH web pages on December 4, 2017. Previous CDRH New items can be found on the CDRH New webpage.
- Webinar - Technical Considerations for Additive Manufactured Medical Devices - January 10, 2018
- MQSA National Statistics
- Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff
- Webinar - FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - January 16, 2018
- Press Release: Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
- Federal Register: Categorization of Investigational Device Exemption Devices to Assist the Centers for Medicare and Medicaid Services with Coverage Decisions
- Federal Register: Technical Considerations for Additive Manufactured Medical Devices
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