CDRH New - March 9, 2021

March 9, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 8, 2021. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Alinity m Resp-4-Plex (Abbott Molecular Inc.)
  • NxTAG Respiratory Pathogen Panel + SARS-CoV-2 (Luminex Molecular Diagnostics, Inc.)
  • CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)
• Re-issued Emergency Use Authorizations
  • binx health At-Home Nasal Swab COVID-19 Sample Collection Kit (binx health, Inc.)
• Updated Emergency Use Authorizations
  • Ambry COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• CDRH Industry Basics Workshop: Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot - April 13, 2021
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200006 added)
• Consumer Information on: Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBsCalCheck – P190034
• Update: Medical Device Types to Help Determine Section 506J Notification Obligations