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2023 PRIM&R Annual Conference

Research Involving Data and Biospecimens

FDA Regulated Research

H11 - [IN-PERSON ONLY] When Secondary Data Use Involves an FDA Regulated Device Study

Wednesday, December 6, 2023
1:45 PM – 2:45 PM ET
Location: Room 202 AB
Human Subjects Research Learning Lab Series CIP Accredited
This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

Secondary research with data can trigger FDA’s investigational device regulations when a data algorithm is developed with the intention to diagnose, treat, mitigate, or prevent and/or cure a disease or condition, and therefore meets the regulatory definition of a medical device. Both investigators and IRBs may not recognize that the research involves an investigational device, and often struggle with interpreting and applying the relevant regulations. As research with machine learning and artificial intelligence (AI) increases, it is becoming even more confusing. In this session, case studies will be used to identify and apply the relevant regulatory frameworks including how to make risk determinations and how to assess AI-system risks. 

Learning Objectives:

  • Recognize when data algorithms used in research are investigational medical devices subject to FDA regulations
  • Understand how differences in Common Rule and FDA regulations impact the need for IRB review of secondary research using data
  • Learn to correctly apply the device regulations to common scenarios involving data research