WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.

1. The FDA Early Feasibility Study Pilot
and the Innovation Pathway
Andrew Farb, MD and Dorothy Abel, BSBME
Division of Cardiovascular Devices
Center for Devices and Radiological Health (CDRH)
andrew.farb@fda.hhs.gov
Medical Device Innovation 2013: The FDA Town Hall
CRT 2013
Washington, DC
February 26, 2013
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2. Disclosures
No conflicts of interest to report.
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3. Climate Change at FDA
FDA recognizes:
•Advantages for the device development process with US clinical
studies (including FIH and early feasibility studies)
– Opportunity for close contact between developers & investigators
– Early access to promising novel technology
– Continuity of clinical investigations
•Human costs associated with delaying access to new technology,
in the context of the limitations of current treatment alternatives
•A need for a cultural change to shift the focus from not only
protecting public health but also to promoting public health
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4. Words into Deeds
The core principle in meeting these priorities is the
application of benefit/risk principles throughout
regulatory decision‐making
•The Innovation Program
– Priority review program for innovative devices with promising
and potentially far reaching benefits
– Entrepreneurs‐in‐Residence Program to enhance regulatory
science
•Early Feasibility Study Guidance
– Use of benefit/risk principles to justify study initiation
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5. Benefit‐Risk Principles
Allow regulators to consider:
•The totality of the benefit/risk profile for the device, for
example:
– Disease condition (e.g., life‐limiting, life‐threatening)
– Limitations of and risks associated with currently available
therapies
•Patient tolerance for risk & perspective on benefits
•Risk mitigation strategies when balancing risks and
benefits
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6. INNOVATION
PAT H W AY

7. The Innovation Pathway
• Priority review program launched February 2011 intended
to:
– Shorten the total time to market
– Transform the FDA/innovator experience
• Targeted for pioneering technologies that address unmet
clinical needs and have the potential to revolutionize
patient care or health care delivery
• Early and intensive investment of resources
– Sponsor/FDA collaboration early in the device development
process to identify the appropriate and least burdensome pathway
to market
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8. Innovation Pathway 2.0:
End Stage Renal Disease Innovation Challenge
(32 Applications Received, 3 Chosen)
CreatiVasc
Hemoaccess
Valve System
UCSF
bioimplantable
artificial kidney
BPTi
Wearable
artificial
kidney
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9. Entrepreneurs‐In‐Residence (EIR) Program
• Recruitment of entrepreneurs and innovators
working with government employees
• Time‐limited (6 months) participation
• Intended to deliver transformational change
via principles of lean engineering in rapidly
testing, validating and scaling new approaches
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10. Current EIR Projects at CDRH
1. Streamlining clinical trials: Find ways to reduce the time
and cost of clinical trials in support of FDA approval or
clearance of medical devices
2. Streamlining the FDA approval‐to‐CMS coverage
pathway: Find ways to reduce the inefficiencies and delays
in data collection to support FDA approval and CMS coverage
3. Striking the right balance between pre‐ and post‐
market evidentiary requirements: Find ways to allow
efficient use of pre‐market studies to allow for timely
approvals, with greater emphasis on capturing informative
real‐world data in post‐market studies
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11. EFS Pilot Program
• Pilot program of 8 innovative device technologies is underway to
implement and evaluate the draft EFS guidance
• Purpose of the Pilot
– Identify strengths and FDA
weaknesses of the guidance
document
• Assess whether adequate
guidance is provided toward
targeting IDE approval Sponsor
• Status of the Pilot
– Pre‐IDE and IDE FDA/sponsor
interactions are ongoing

12. FDA EFS Guidance Revisions
Based on Pilot Experience and Comments
• Emphasized benefit/risk concepts throughout the document
• Improved the Report of Prior Investigations section to clarify
the information that will be useful to justify study initiation
– Expanded on the Device Evaluation Strategy
• Included device design information and clinical protocol risk mitigation
strategies in the table to provide the appropriate context when considering
benefit/risk
• Added a Design Control section
• Included more guidance on drafting the informed consent form
for an EFS
• Suggested pre‐submission topics for discussion between the
sponsor and FDA
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13. FDA EFS Guidance Update
• Although new pilot projects are not being accepted, EFS
IDEs may be submitted prior to the publication of the final
guidance.
• Many sponsors have committed to conducting EFS studies
in the US.
• Publication is anticipated soon.
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14. Parting Thoughts
• Early and continuous interaction between FDA and
sponsors will be instrumental in FDA’s efforts to
facilitate innovation
• Accelerating innovation involves getting to the
answers quicker and not just shortening the time to
market or reducing regulatory requirements
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15. Contacts
• Early Feasibility Study
Guidance
Dorothy.Abel@fda.hhs.gov
Andrew.Farb@fda.hhs.gov
• Innovation Pathway
Murray.Sheldon@fda.hhs.gov
Associate Director for Technology & Innovation, CDRH
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