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Early Feasibility Studies for Medical Devices: FDA Guidance and Program Updates

Learn about EFS objectives, scope, JITT, device iteration, FDA guidance, and more to enhance collaboration and protect study participants.

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Early Feasibility Studies for Medical Devices: FDA Guidance and Program Updates

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  1. ISCTR 2018 San Diego, CA September 21, 2018 Early Feasibility Studies for Device Evaluation Andrew Farb, MDCo-Leader of the Early Feasibility Studies ProgramCenter for Devices and Radiological Health (CDRH)Food and Drug Administrationandrew.farb@fda.hhs.gov

  2. Disclosure Statement of Financial Interest I, Andrew Farb, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation

  3. Purposes of Early Feasibility Studies OBTAIN INSIGHTS Early clinical experience • Provides the basis for iteration & product improvement • Integral to the device development process

  4. Acknowledging Problems With Medical Device Innovation and Development in the US • Migration of initial clinical testing of novel devices overseas • Growing time lag in the access to beneficial medical devices for US patients • Delay in physician experience with new products • Concern that device innovation may follow overseas US was the 42nd nation to approve a TAVR device Many clinical trial ecosystem factors contributed to these trends including FDA’s requirements to initiate clinical studies of new devices in the US

  5. EFS Guidance Scope • Elements that define an EFS: • Small number of subjects • Device may be early in development and before the device design has been finalized • Does not necessarily involve the first clinical use • Needed when information to advance device development cannot be practically obtained with additional nonclinical assessments, or nonclinical tests are unavailable

  6. EFS Program Objectives • Re-establish/increase US participation in the early clinical evaluation of innovative medical devices under the current IDE regulations • Provide the earliest patient access to potentially beneficial medical devices in the US • Enhance collaboration among device developers, industry, regulators, and investigators • Protect study participants

  7. EFS Guidance • Key Guidance Principle – EFS IDE approval may be based on less nonclinical data than would be needed to support a larger clinical study of a more finalized device design • Guidance Provisions – New ways for sponsors and regulators to justify and support transitioning from bench to bedside with an increased focus on: • Clinical condition • Availability, benefits, and risks of alternative treatments • Risk mitigation strategies, enhanced monitoring, and a tailored consent process to enhance patient safety

  8. Just-In-Time Testing (JITT)Doing the Right Testing at the Right Time • It may be acceptable to defer some nonclinical testing until the device design has been finalized for use in a pivotal study in a larger number of patients • Comprehensive testing in early phases of device development may add cost without return • Some tests have limited applicability if the device is modified • Conducting non-informative testing delays device access to patients who may have limited alternatives

  9. Device Iteration During an EFS • Experience and knowledge gained from initial study subjects can guide device or protocol changes • Rounds of regulatory submissions and review can delay the implementation of changes and impede study progress The EFS Guidance includes new tools to facilitate timely device and clinical protocol modifications: • 5-day notices • Contingent approval • Interactive review

  10. Within 2 weeks of receipt of Pre-Sub Suggested EFS Pre-IDE Submission Timeline Goals Within one month of receipt of Pre-Sub • Pre-submission informational meetings can jumpstart interactions between sponsors and FDA reviews teams Within 45-55 days of receipt of Pre-Sub Within 60 days of receipt of Pre-Sub

  11. Early Feasibility Study IDEs Finalized EFS Guidance document issued October 1, 2013 80% of EFS IDE submissions approved in 1 review cycle EFS IDEs Submitted Growing interest in US EFS from non-US sponsors EFS IDEs Approved US EFS used to support CE Mark Transition from US EFS to pivotal studies

  12. FDA Value of Interactions and Application of Just-In-Time Testing (JITT) Principles Beyond EFS Sponsors Innovators & Investigators • Familiarity with the technology and regulatory considerations throughout product development • Consensus on data requirements to move forward from bench to clinical use • Smoother transitions between types of clinical studies

  13. Established by the 21st Century Cures Act and supersedes the Expedited Access Pathway • Accelerated pathway for devices that FDA finds could provide more effective treatments or diagnose life-threatening or irreversibly debilitating diseases or conditions, particularly those that address unmet needs • Allows consideration of 510(k) products • Highly interactive • Sprint discussions to facilitate agreement between FDA and sponsors on product development topics within a set period of time • Regular status update meetings

  14. The EFS Program Within FDA Strategic Priorities Our Measure of Success: “By December 31, 2020, more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets.” Mission: Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. CDRH Leadership Committed to the Success of the EFS Program https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM592693.pdf

  15. Building a Successful US EFS Ecosystem JACC 2016;68:1908-15 • Gov’t: FDA and CMS • Industry Sponsors • Inventors/Innovators • Investigators • Clinical Sites • Private Funders and Payers • Study subjects • IDE approval • IRB approval • Insurance coverage • Contracting and indemnification • Site start-up • Patient enrolment

  16. Addressing the Clinical Trial Ecosystemto Improve the Climate for US EFS Ongoing multi-stakeholder effort organized under the Medical Device Innovation Consortium (MDIC) • Collaboratively develop and adopt best practices of study conduct • Participants: Industry, FDA, CMS, clinical sites, investigators • Working groups: • Administrative and Clinical Practices • Reimbursement • Patient Advocacy • Vision: A voluntary, open research network of clinical sites in a consortium that are committed to high quality, efficiently executed EFS

  17. What’s Working Well FDA Approvals and Site IRB Reviews MDIC Collected data from 13 EFS Company Sponsors on study and site performance. Data collected April-Sept 2017 from Studies performed in 2015/16/17 Slide courtesy of Chip Hance, TCT Conference 2017

  18. Room for Improvement Site Contracting and Patient Enrollment MDIC Collected data from 13 EFS Company Sponsors on study and site performance. Data collected April-Sept 2017 from Studies performed in 2015/16/17 Slide courtesy of Chip Hance, TCT Conference 2017

  19. Cardiovascular Devices EFS Pilot • Pilot initiated, centrally administered by the MDIC (http://mdic.org/cts/efs/) • >30 US clinical research sites interested in participating • Agreement to test drive tools to increase efficiency of the EFS start-up process • Master clinical trial agreement (MCTA) • Informed consent document template • Educational materials for IRBs, research staff, and study subjects • Collection of de-identified EFS performance metrics for process improvement • Public presentations of progress MCTA key topic areas • IP protection • Confidentiality • Indemnification • Insurance coverage 60/60 EFS goal: First 60 days for IRB and contract approval/Next 60 days to first patient enrolled

  20. FDA’S Role in the US EFS Ecosystem • The EFS Program is integral to FDA’s mission and has fostered a paradigm shift in performing early phase device studies in the US. • FDA continues to facilitate interactions among stakeholders to address site start-up challenges. Improving the EFS ecosystem requires the commitment of industry, investigators, and clinical sites.

  21. Resources • EFS Website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm572934.htm • EFS Guidance document: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM279103.pdf2 • Pre-Submission Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf • EFS CDRH Learn modules: http://www.fda.gov/Training/CDRHLearn/ • FDA Categorization of Investigational IDE Devices Draft Guidance document: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm504091.pdf

  22. CDRH Division EFS Contacts https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm572934.htm General inquiries: CDRH_EFS@fda.hhs.gov

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