Webinar: Early Feasibility Studies

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Overview

Many IRBs may be unfamiliar with EFS, but their prevalence in the US is increasing. FDA's EFS Guidance document, "Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies" (published October 1, 2013), describes regulatory considerations specific to early-stage clinical evaluations. IRB review of EFS can be challenging because these types of studies often have more uncertainty with regards to safety and effectiveness than studies involving more mature device technologies or well-established uses. An understanding of key EFS principles is important so that medical device innovation to address clinical needs can proceed along with appropriate subject protection measures.

During this intermediate-level webinar, Andrew Farb, MD, a medical officer and senior reviewer in the Division of Cardiovascular Devices at FDA's Center for Devices and Radiological Health (CDRH) will:

  • Define EFS, explain why they are a priority for the US, and describe how EFS differ from other types of medical device clinical evaluations
  • Discuss the information that supports the initiation of an EFS, and how this may be different from the information needed to support initiation of a pivotal study or a marketing application
  • Describe policies to facilitate device and protocol changes during an EFS
  • Explore IRB considerations for overseeing EFS including risk determination and mitigation, periodic reporting, informed consent, and centralized or single IRBs

What will I learn?
After attending this webinar, attendees will be able to:

  • Define and recognize EFS
  • Understand FDA’s process for approving EFS IDEs
  • Understand the IRB’s role in protecting EFS subjects and mitigating risks

Who should attend?
IRB staff and members as well as researchers who are involved with or will be involved with conducting or overseeing investigational device research should attend this webinar.

Faculty

Andrew FarbAndrew Farb, MD is a medical officer and senior reviewer in the Division of Cardiovascular Devices at FDA's Center for Devices and Radiological Health (CDRH). He is a graduate of Dartmouth College (BA) and Cornell University Medical College (MD). He completed an internship and residency in internal medicine, a one-year residency in anatomic pathology, and a fellowship in clinical cardiology at The New York Hospital – Cornell Medical Center. Following a fellowship in cardiovascular pathology at The Armed Forces Institute of Pathology (AFIP), he served as a staff cardiovascular pathologist at AFIP with research interests in and publications on coronary atherosclerosis and mechanisms of thrombosis, coronary artery interventions, and structural heart disease. He joined the FDA in 2004, where he has concentrated on clinical study design and regulatory review of interventional cardiology, structural heart (including left atrial appendage occlusion devices), and peripheral vascular devices as well as providing guidance on pre-clinical animal testing. His most recent work at the Agency has focused on early feasibility and first-in-human studies. He co-authored FDA's Guidance document entitled "Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies," and he is the Clinical Consultant to CDRH's Early Feasibility Study Program. In addition to his position at FDA, he provides cardiovascular pathology consultations and engages in direct patient care as an attending physician in clinical cardiology.

Background Reading

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies, US Department of Health and Human Services

Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification

Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 60-minute webinar counts as 1 CE credit hour. Additional information about recertification can be found here.

Contact Information

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