Investigational Device Exe

(IDEs) for 

Early Feasibility 

Medical Device Clinical S

Andrew Farb, MD and Dorothy Ab

Office of Device Evaluation

Center for Devices and Radiological He

Food and Drug Administratio
Opportunities Associated 

US Early Feasibility Studies 

• Contact between inventors, deve

investigators, and regulators 

– Geographically closer – More collaborative 

• Access to promising novel techno

– Earlier – Continuous – Expanded 
Goals

1. Providing the earliest and broad

access to beneficial medical de

2. Maintaining or regaining US lea

innovation 
Prevailing Currents 

• Initial clinical testing of novel de

been moving to non-US sites 

• Device innovation may follow ov• Devices are being developed ex

for non-US markets 
Consequences 

• Palpable time lag in the availabil

some beneficial medical devices patients 

• Human costs associated with de

access to new technology (particthe context of the limitations of ctreatment alternatives) 
Barriers to Innovating in th

• Insufficient predictability of what i

needed to allow for the initiation of c

– Data requirements can be difficult to identify 

• Increasingly complex devices • No established guidance or standards for in

• No generally accepted method for justifying 

• Ineffective communication betwee

industry 

• Poor-quality submissions that do 

coherently describe relevant informa
FDA Commitment 

• The FDA recognizes the value of en

medical device innovation to addresneeds and improve patient care 

• FDA is committed to improving U.S

access to new devices by strengthestreamlining the clinical trial enterpr

• FDA has focused efforts on promot

health 
New Framework

• The core principle is the application 

principles throughout regulatory dec

– Keep the clinical context at the forefron

• Allows regulators to consider: 

– The totality of the benefit/risk profile for 

example: 

• Disease condition (e.g., life-limiting, life-thre• Limitations of and risks associated with curr

therapies 

– Patient tolerance for risk & perspective – Risk mitigation strategies when balanci

benefits 
Early Feasibility Study (EFS) G

• Intended to facilitate the clinical evaluation 

devices in the US under the InvestigationaExemptions (IDE) regulations, using risk mstrategies that appropriately protect study 

• Elements that define an early feasibility stu

– Small number of subjects – Device intended for a specific indication that ma

development, typically before the device design finalized 

– Does not necessarily involve the first clinical us
Guidance Provisions: a Regulat

Enables sponsors and regulators new ways about: 

– Device development – The appropriate evidence neede

from bench to clinical study 

– The implementation of timely dev

clinical protocol modifications 
Key Principle of the Guida

Approval of an early feasibility study based on less nonclinical data 

– For some new devices, exhaustive no

testing would not likely provide the inneeded to further device developmen

– In these cases, early clinical use of th

limited number of subjects is needed 

• provide initial insights into clinical saf

function; 

• inform subsequent clinical and non-c

and/or 

• improve device performance through 

finalizing the design 
Just-In-Time (JIT) Testi

A guiding principle of the EFS Gui

• Applies to the type and timing of nonclini

needed to justify study initiation 

– Departs from the custom of expecting exhaus

testing prior to any clinical use 

– Recognizes that comprehensive testing durin

device development may add cost without ret

• Testing could have limited future applicability i

• Time-consuming, non-informative testing delay

device for patients who may have limited treat

• Includes acknowledgement that it may b

defer some testing until the device desigfinalized for use in a pivotal study 
Other Reasons Why JIT i

• An early feasibility study incorporates 

mitigation strategies and patient protemeasures as compared to a pivotal st

• Highly selected patients will be enrolle

receive individualized care and monito

• The guidance does not recommend th

prematurely initiate clinical testing wheuseful and appropriate nonclinical testperformed to advance the device’s de

An EFS must be supported by an a

benefit/risk analysis, including justificatio

and amount of data needed to support s
JIT in Practice: 

Device Evaluation Strategy 

A “Device Evaluation Strategy” withReport of Prior Investigations is needescribe and justify the appropriate support initiation of the clinical stud

– Provide the “thinking” behind the de

development program

– Justify what is sufficient, rather than 

the sake of testing 
Device Evaluation Strateg

• Support basic device functionality 

– An expectation of acceptable clinical use an

will function as intended 

• Address significant safety concerns 

– Address basic device safety, including, but n

sterility, biocompatibility, electromagnetic cochemical compatibility (e.g., with concomitanchemicals, cleaners) 

– Characterize catastrophic failure modes and 

associated risk mitigation approaches
Device Evaluation Strategy Me

The design concept, including the context for the device design, provfoundation for the device evaluatiowhich involves identifying: 

– Device and procedure-related attributes n

obtain the desired performance, 

– Failure modes that might occur if each at

achieved, 

– How the failures could affect the device o– What information is needed or available t

attribute or failure mode. 
After Study Initiation: 

Iterative Device Development Pro

• Experience and knowledge gained from i

subjects can guide device or protocol cha

• Rounds of regulatory submissions and re

the implementation of changes and imped

• The EFS G

includes nto facilitate and clinicamodificatioearly feas
New Approaches

1. More changes can be made through 5-d

rather than requiring FDA approval 

– Many changes will not affect the interpretation 

results do not depend on statistical analyses or study subjects 

2. Contingent approval 

– Approval of anticipated or proposed device cha

contingent on the completion of an agreed-uporeporting of test data 

– After successful completion of testing, the spon

study the modified device without additional FD

3. Interactive review 

– Encourages communication between FDA and 

the 30-day review cycle to address deficiencies 
Next Steps

Subsequent clinical evaluation depstability of the device design, the avdata to justify the next study, and thof the clinical study 

– Expansion of the early feasibility study 

• e.g., further device iterations are expected 

– Either a traditional feasibility or a pivot

• Device design is near-final or final, • Early feasibility study results support the in

device and proof of principle, and 

• Adequate non-clinical data are available 
Update: EFS Guidance Rev

Based on Pilot Experience and Com

• Emphasized benefit/risk concepts 

the document 

• Improved the Report of Prior Inves

section to clarify the information thuseful to justify study initiation 

• Added a Design Controls section 

• Included more guidance on draftin

informed consent form for an EFS 

• Suggested pre-submission topics 

discussion between the sponsor a
Current Efforts and Remaining Un

• Intra- and extramural training programs a

developed 

• Many sponsors have committed to ‘test th

conducting EFS studies in the US 

• Outstanding questions: 

– Will other sponsors take the plunge? – Is there sufficient value-added in doing US EF– Are the non-regulatory, clinical trial challenges 

surmountable?
Additional Information

• Early Feasibility Study Guidance available 

http://www.fda.gov/downloads/MedicalDevices/DevonandGuidance/GuidanceDocuments/UCM279103

• EFS questions? 

andrew.farb@fda.hhs.gov dorothy.abel@fda.hhs.gov