Coronavirus (covid-19) Update: FDA New Policy to Expedite Availability of Diagnostics

Casper (Cap) Uldriks

Starting at

$349


Buy Now

Background:

The FDA can issue an Emergency Use Authorization (EUA) to permit the use of a regulated product outside of the FDA’s established regulatory requirements. FDA’s decision to issue a EUA relies on scientific data that suggests a particular medical product may be effective in diagnosing, treating or preventing a disease or condition when and the benefit out ways the risk. FDA uses a EUA when the Public Health Service (PHS) and the Department of Health and Human Services (HHS) determines there is a public health emergency or significant potential for a public health emergency. The current COVID-19 pandemic represents a clear example of what warrants an EUA.

Description:-The webinar will cover the FDA’s new policy for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests. The FDA can issue a EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by HHS, that there is a public health emergency or significant potential for a public health emergency.

The audience will be benefited by learning how laboratories can develop and begin to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests. The FDA can issue a EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by HHS, that there is a public health emergency or significant potential for a public health emergency like the Corona Virus.

Why attendees should register:

EUA permits the use of a coivd-19 test that has not been fully validated by you or evaluated by the FDA. The burden of assuring the accuracy of the diagnostic test rests with the manufacturer or a third party or hospital laboratory that develops a test without the benefit of a clinical trial to determine the degree of the test’s sensitivity and accuracy. A false-negative test result could be fatal for the test subject. You need to understand what you can and cannot do under a EUA and how much information the clinical technicians and healthcare professionals need to use the test. For the sake of the consumer, what kind of informed consent is required and who bears the liability for the product’s failure?  What kind of changes will you make to your COVID-19 test based on evolving real-world evidence? Can the data from clinical outcome reports be used to support a 510(k) submission? As you move forward, collecting and analyzing your real-world data will be critical. 

Areas Covered in the Webinar Session:

  • Public Health Coronavirus crisis in the U.S.
  • Background on U.S. Coronavirus needs for Diagnostic Testing
  • FDA’s new policy to Expedite Availability of Diagnostics & Diagnostic Testing
  • Emergency Use authorization for COVID-19 Diagnostics
  • How laboratories can develop and begin to use validated COVID-19 diagnostics before FDA completes a review of their Emergency Use Authorization.

Learning Objectives:-

  • Public Health Coronavirus crisis in U.S. Status
  • Background on U.S. Coronavirus needs for Diagnostic Testing
  • FDA’s new policy to Expedite Availability of Diagnostics & Diagnostic Testing
  • Emergency Use authorization for COVID-19 Diagnostics
  • How laboratories can develop and begin to use validated COVID-19 diagnostics before FDA completes a review of their Emergency Use Authorization.

Who will benefit: 

  • Manufacturer Regulatory Affairs Directors
  • Laboratory Directors
  •  Institutional and Clinical Risk Managers

Target Companies: 

  • FDA Registered In-Vitro Diagnostic Manufacturers
  • Healthcare Institutions
  • Public Health Service (state and county)
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Casper (Cap) Uldriks, Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.


Follow us

24x7 Direct Number
(315) 632-0735,
(315) 750-4379
Toll Free
1-866-978-0800

Fax

1-888-883-7697