On-Demand Webinar

Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software

Clinical decision support (CDS) software is a challenging regulatory space. Should it be regulated as a device? And if it is a device, what does that mean for the software development and testing?

FDA recently published final guidance on the topic, and while the document provides some helpful clarifications, there are still areas that remain a little perplexing.

Conquer the confusion with this webinar, presented by device regulatory experts Alethea Wieland, President & COO of Clinical Research Strategies and Managing Expert at Advarra Consulting, and Advarra IRB Chairpersons Robert Romanchuk and Erin Odor. In addition to providing an overview of the final guidance, they will also conduct a roundtable discussion of case studies to help attendees better understand how the guidance and other device regulations might and might not apply.

Learning Objectives:

  • Describe the criteria for assessing whether CDS software is regulated as a medical device
  • Explain the impact of certain regulatory designations on CDS software development and marketing
  • Assess CDS software projects to determine the appropriate regulatory pathway

Presented By


Alethea Wieland

President and CEO, Clinical Research Strategies


Robert Romanchuk

IRB Chairperson


Erin Odor


IRB Chairperson

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Who should watch?

This content applies to research sponsors involved in clinical and regulatory activities for CDS software, IRB representatives and involved in reviewing CDS software research, investigators and other research professionals designing and conducting research involving CDS software, and innovators and software developers building CDS software for the clinical space.

CE Credits

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

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