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.(Presented on March 22, 2017)
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.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1 continuing education credits towards CIP recertification. Learn More »
Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.
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