CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 15, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 14, 2020. To view listings for other dates, see CDRH New - News and Updates.

• Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin - Draft Guidance for Industry and Food and Drug Administration Staff

• Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff
• Consumer Information on: LIAISON® XL MUREX HBc IgM, LIAISON® MUREX Control HBc IgM – P180045
• Consumer Information on: LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
• Presentation and Transcript posted for Respirators and Other PPE for Health Care Personnel Use Webinar - September 29, 2020
• EUA Authorized Serology Test Performance (Updated)
• Federal Register: Guidance - Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
• Federal Register: Guidance - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
• Federal Register: Requests for Nominations - Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee