We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Grants Emergency Use to Arbor Vita’s Influenza A Assay

FDA Grants Emergency Use to Arbor Vita’s Influenza A Assay

June 20, 2014

U.S. government and foreign laboratories may now use Arbor Vita’s A/H7N9 Influenza Rapid Test to confirm or rule out infection with the H7N9 strain of influenza A in patients showing signs of respiratory illness.

The emergency use authorization, granted April 25 and posted online Monday, requires Arbor Vita to distribute the rapid test fact sheets for healthcare professionals and patients to laboratories and online, ensure that laboratories using the test at home and abroad have an adequate means of reporting test results to healthcare workers and federal and state authorities, track and report adverse events and false positive and negative results and keep records of device usage.

The company must also make clear in its labeling and marketing tools that the test is not currently FDA-approved.

The FDA’s Emergency Use program allows the commissioner to grant use of an unapproved medical device or unapproved use of an approved medical device “during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.”

Arbor Vita applied for emergency use of its A/H7N9 test on April 9, claiming that rapid, simple, and affordable detection of the virus could serve as a critical juncture in halting the virus’ spread.

A/H7N9 was first reported in humans in China in March 2013. Most cases have resulted in severe respiratory illness, according to the Centers for Disease Control and Prevention, and a third of the victims have died. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Medical Devices Regulatory Affairs Commercial Operations
  • Related Events

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

Upcoming Events

  • 21Jan

    Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Purple_Approved_Stamp.gif

    Seno Medical Gets Premarket Approval for Breast Cancer Diagnostic

  • Triple Vaccine, needles

    Moderna to Start New Trial Adding Third Shot of COVID-19 Vaccine

  • Supreme Court Rejects Merck’s Appeal for $2.5 Billion Patent Verdict Reinstatement

  • FDA clears text

    FDA Clears SCC’s Transfusion-Management Software

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing