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COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response

RAC Credits
Virtual Programs
Thursday, 10 February 2022 (1:00 PM) - Thursday, 10 February 2022 (2:00 PM) Eastern Time (US & Canada)

As COVID-19 swept across the world, governments and companies raced to develop tools to slow the spread of SARS-CoV-2.

COVID-19 tests are a critical component of the fight against the pandemic and test developers answered the call to provide tests to meet the demand. Several high-profile instances of false negatives and false positives, combined with the potential for these false results to impact businesses and schools that have included testing as part of their back-to-work/school strategies, opening the doorway to potential product liability litigation for the test developers.

This presentation will discuss the scientific and regulatory issues of COVID-19 tests. First, we will present the scientific basics of SARS-CoV-2 and what biomarkers are used to detect COVID-19. This section will include an overview of the types of COVID-19 tests and a discussion of the factors that impact accuracy, detailing both those that the developers can control and those they cannot. Second, it will cover the regulatory landscape, providing an overview of the FDA Emergency Use Authorization Guideline and how the guidance has changed over time. This part of the presentation will include a comparison between the 510(k) and various EUA pathways, how the definition of ‘State of the Art’ has changed with reference to the scientific background established previously. Lastly, the program will take a look at the various types of issues the FDA has worked through over the course of the pandemic to date.



Learning Objectives

Upon completion of this program, attendees will be able to

  • Describe the various types of tests used during the SARS-CoV-2 pandemic.
  • Name and understand the different responses from the FDA in response to the SARS-CoV-2 pandemic.

Pricing Amounts & Deadlines 


Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.


Christie Bergerson

Alexis Sauer-Budge

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email