CDRH New - September 25, 2020

CDRH New

September 25, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 24, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Clear Dx SARS-CoV-2 Test (Clear Labs, Inc.)
  • Orawell IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd.)
• Updated Emergency Use Authorization
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
• Re-Issued Emergency Use Authorization
  • BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company)
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
• Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
• Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances - October 22, 2020
• Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
• Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - September 29, 2020
• Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication
  • Information for Patients About Dental Amalgam Fillings
• Presentation and Transcript added to Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic Webinar - September 15, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• Federal Register: The Accreditation Scheme for Conformity Assessment Pilot Program