2014 Webinar: Investigator-Initiated Device Studies

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Overview

US Food and Drug Administration (FDA) approval of an investigational device exemption (IDE) is required for studies of significant risk devices that involve human subjects and are not approved or cleared for the indication being studied. The process of applying for an IDE can be challenging for institutional review boards (IRBs) and investigators. 

In most academic centers, investigators rely on IRBs for guidance with the IDE submission and approval process. This webinar provided the tools for determining whether an IDE is necessary, charting a timeline for the application process, and identifying the respective responsibilities of investigators and IRBs. The webinar covered the following topics:

  • Is an IDE needed?
    To assist the investigator in making this determination, the IRB needs to understand the goals of the study and whether the proposed research presents significant risk.
  • Application process
    If it is determined that an IDE is needed, IRB review must focus on the unique characteristics of device studies. Presenters highlighted the distinctions between device and drug studies as they pertain to IRB and FDA review, and identify key pieces of information that investigators need to present to the IRB and/or include in an IDE submission to FDA.
  • Deciphering the FDA decision letter
    The FDA decision letter will fully approve, approve with conditions, or disapprove the IDE. Presenters reviewed each of these potential decisions and offer insight into their implications. 
  • Role of the IRB in the subsequent steps
    If the IDE is approved with conditions or disapproved, FDA’s decision letter will ask the investigator to respond to certain questions. If the IDE is fully approved, the sponsor may begin enrollment in the study without being subject to such requirements. The presenters discussed how IRBs can assist investigators in preparing responses to FDA as well as in successfully initiating the IDE study.

Audience
This intermediate-level webinar was of interest to investigators, IRB members and staff, and others involved in applying for and reviewing research with IDEs.

Faculty

Owen Faris, PhD, is the deputy director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health (CDRH) within the FDA. Dr. Faris received his BS in mechanical engineering from Rice University in 1997, and his PhD in Biomedical Engineering from Johns Hopkins University in 2003. He has been with FDA since 2003. In addition to managing the Division of Cardiovascular Devices, Dr. Faris has been very involved in the development of clinical trial policy for all of CDRH. Dr. Faris was the lead author in the recent Draft Guidance document: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations. He is very interested in better understanding the needs and concerns of the IRB community as they relate to CDRH policies, decisions, and outreach regarding clinical studies for medical devices.

Soma Kalb, PhD, is the acting director of the IDE program at the CDRH within FDA. Dr. Kalb received her BS in electrical engineering from the University of Maryland in 1995, her MSE in biomedical engineering from the Johns Hopkins University in 1997, and her PhD in biomedical engineering from Duke University in 2004. She has been with the FDA since 2005, where she began as a research scientist and reviewer of post-market medical device reports. Since 2007, Dr. Kalb has been in the Office of Device Evaluation, first as a reviewer in the Division of Cardiovascular Devices, and now as the Acting Director of the IDE Program. Dr. Kalb has been involved in both review of clinical trials as well as policy development and implementation for CDRH. 

Matthew Wladkowski, MS, RAC, is a clinical project manager for New England Research Institutes, Inc. He has several years of experience managing complex programs in translational and clinical research developing novel therapeutics and devices, from discovery through development and manufacturing, into clinical trials. His previous work involved many aspects of the regulatory process, including working in the Translational Research Program at Boston Children’s Hospital as the Regulatory Affairs Coordinator where he submitted IND and IDE applications and consulting the IRB on FDA matters and as the Research Compliance Officer at Massachusetts Eye and Ear Infirmary where he oversaw the IRB and IACUC. Matt is a certified regulatory affairs professional (RAC) and earned a master’s degree in Regulatory Affairs from Northeastern University.

Certificates of Attendance

Certificates of attendance for the Investigator-Initiated Device Studies: How IRBs Can Help Researchers Work with the FDA webinar were 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.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email us or call 617.423.4112, ext.0.

CE Credit for Certified IRB Professional (CIP®) Recertification

Webinar participants holding the CIP credential who wish to apply credits from Investigator-Initiated Device Studies: How IRBs Can Help Researchers Work with the FDA toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.