CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 18, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 17, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Visby Medical COVID-19 (Visby Medical, Inc.)
  • MAGLUMI 2019-nCoV IgM/IgG (Shenzhen New Industries Biomedical Engineering Co., Ltd.)
• Virtual Public Meeting - FDA's Communications About the Safety of Medical Devices - November 17, 2020
• Presentation and Transcript added to Webinar - Multiple Function Device Products: Policy and Considerations - September 10, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• Federal Register: Microbiology Devices: Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management