Welcome to today’s

FDA/CDRH Webinar

Thank you for your patience while we register all 

of today’s participants.

If you have not connected to the audio portion of the 

webinar, please do so now:

Dial: 800-369-1937 

International Callers Dial: 1-312-470-7075 

Passcode:5211887
Strengthening the Medical 

Device Clinical Trial 

Enterprise

Owen Faris, Ph.D.

Clinical Trials Director (acting)

Office of Device Evaluation

Center for Devices and Radiological Health
Please help us help you

• CDRH would like to better understand your training 

and communication needs regarding medical device 

clinical trials

• We will be asking you to complete a short survey

• Results will inform our future clinical trials 

outreach efforts

• Survey link: https://www.research.net/s/fdamdct

3

Survey link: https://www.research.net/s/fdamdct
Outline

• Overview of CDRH’s 2014-15 Strategic Priorities

• Clinical trial enterprise priority

• CDRH’s recent efforts and results

• Focus on Early Feasibility Studies (EFS)

• Future plans

4

Survey link: https://www.research.net/s/fdamdct
5

CDRH Strategic Priorities 2014/2015 

• Strengthen the Clinical Trial Enterprise 

• Strike the Right Balance Between Premarket and 

Postmarket Data Collection 

• Provide Excellent Customer Service 

Survey link: https://www.research.net/s/fdamdct
Strengthening the Clinical Trial 

Enterprise 

• Goal: Improve the efficiency, consistency, 

and predictability of the IDE process to 

reduce the time and number of cycles needed 

to reach appropriate IDE full approval for 

medical devices, in general, and for devices 

of public health importance, in particular.

• Goal: Increase the number of early 

feasibility/first-in-human IDE studies 

submitted to FDA and conducted in the U.S. 

6

Survey link: https://www.research.net/s/fdamdct
The IDE Challenge

• The IDE review process is an important part to 

protecting subjects in investigational device 

studies

• We also recognize, the sooner an IDE is 

approved, the sooner a potentially important 

technology can be available to US patients

• The IDE process has at times led to avoidable 

bottlenecks in the process

• We can and should look for ways to improve the 

process of FDA’s decision making for IDEs

7

Survey link: https://www.research.net/s/fdamdct
What is CDRH doing?

• Established Clinical Trials Program and 

Clinical Trials Director (CTD)

• Established SOP for CTD involvement and 

review of certain IDE decisions. Focus on:

• Ensuring CDRH is “in the right place” 

• Ensuring flexibility is applied where appropriate

• Increased communication with sponsors

• Established Early Feasibility Study (EFS) 

coordinators within Clinical Trials Program

8

Survey link: https://www.research.net/s/fdamdct
IDE SOP Provisions

10 Days

FDA offers a 

teleconference to 

clarify reasons for 

decision

9

30 Day IDE Review Round 1 DSAP*

* For Round 1 disapproval (DSAP) and approval with conditions (APCN) decisions, the 

clinical trials director (CTD) may review and request to meet with review team.
IDE SOP Provisions

10

10 Days

FDA offers a 

teleconference to 

clarify reasons for 

decision

CTD included in 

10-day t-con

CTD and team meet internally

30 Day IDE Review Round 1 DSAP*

Round 2 DSAP or APCN

* For Round 1 disapproval (DSAP) and approval with conditions (APCN) decisions, the 

clinical trials director (CTD) may review and request to meet with review team.
IDE SOP Provisions

Round 3+ DSAP or APCN

11

10 Days

FDA offers a 

teleconference to 

clarify reasons for 

decision

CTD included in 

10-day t-con

30 Day IDE Review Round 1 DSAP*

Round 2 DSAP or APCN

CTD notified 5 days prior to decision letter

CTD and team meet internally

* For Round 1 disapproval (DSAP) and approval with conditions (APCN) decisions, the 

clinical trials director (CTD) may review and request to meet with review team.
Clinical Trials Program 

Outcomes

• Helps ensure consistency in decision-making

• Facilitates sharing of best practices across divisions

• Encourages higher levels of interaction

• Helps prepare sponsor to respond

– 10-day meeting

12

Survey link: https://www.research.net/s/fdamdct
FY2014 Goals and Results

By September 30, 2014, compared to FY13 

performance, CDRH sought to:

• Reduce the number of IDEs requiring more than two 

cycles to an appropriate full approval decision by 25%

– Result: 34% reduction

• Reduce the overall median time to appropriate full 

IDE approval by 25%

– Result: 53% reduction

13

Survey link: https://www.research.net/s/fdamdct
FY14 Performance

14

14.8%

43.5%

62.7%

FY11 FY13* FY14*

Percent of IDE Studies Fully Approved within 

Two Cycles

* Values calculated on 10/31/13 and 10/31/14 respectively
15

442

215

101

FY11 FY13* FY14*

Median Days to Full IDE Study Approval

* Values calculated on 10/31/13 and 10/31/14 respectively

FY14 Performance
FY2015 Goals

By June 30, 2015, compared to FY13 

performance, CDRH seeks to:

• Reduce the number of IDEs requiring more 

than two cycles to an appropriate full 

approval decision by 50%

• Reduce the overall median time to full 

appropriate IDE approval to 30 days.

• Increase the number of early 

feasibility/first-in-human IDE studies 

submitted to each premarket Division

16

Survey link: https://www.research.net/s/fdamdct
Early Feasibility Study (EFS) 

Program

• Intent - To facilitate US EFS under the IDE 

regulations 

• Scope - Elements that define an early 

feasibility study:

– Small number of subjects

– Device that may be early in development, typically 

before the device design has been finalized

– Does not necessarily involve the first clinical use of a 

device

17

Survey link: https://www.research.net/s/fdamdct
Purpose of Early Feasibility 

Studies

safety

whether the device 

performs its intended 

purpose 

therapeutic 

parameters 

device 

failures

patient characteristics that may 

impact device performance 

human 

factors 

operator 

technique 

challenges 

18

OBTAIN INSIGHTS

Survey link: https://www.research.net/s/fdamdct
Why focus on EFS?

• EFS is often a critical step in device 

innovation and development

• When EFS are conducted in the US, important 

new technologies may become available to US 

patients sooner. 

19 Survey link: https://www.research.net/s/fdamdct
What is CDRH doing to 

support EFS in US?

• Issued Guidance to outline FDA’s thinking on 

EFS and how FDA can be more flexible

• Established and trained EFS experts in each 

ODE review division to assist sponsors and 

review teams

• Currently developing “CDRH-learn” module 

focused on EFS

20 Survey link: https://www.research.net/s/fdamdct
EFS Guidance

• Key Guidance Principle - Approval of an early 

feasibility study IDE may be based on less 

nonclinical data than would be needed to 

support the initiation of a larger clinical study of 

a more final device design

• Guidance Provisions - A regulatory toolkit that 

enables sponsors and regulators to think in new 

ways about device development

– Justifying the appropriate evidence needed to move from 

bench to clinical study

– Allowing timely device and clinical protocol modifications 

21 Survey link: https://www.research.net/s/fdamdct
The Right Testing at the Right Time

• Comprehensive testing during early phases of 

device development may add cost without 

significant return

• It may be acceptable to defer some 

nonclinical testing until the device design has 

been finalized

• An early feasibility study incorporates 

enhanced risk mitigation strategies and 

patient protection measures as compared to 

a pivotal study

Survey link: https://www.research.net/s/fdamdct 22
EFS Process

• Sponsors contact EFS coordinators and interact 

informally to:

– Discuss the EFS guidance policies and principles

– Help with understanding the device evaluation strategy (DES) 

concept and developing the DES table

– Prepare for initial interactions with the review team

• Submit the initial Pre-Sub

– Reach agreement on the information needed in the Report of 

Prior Investigations to support study initiation

– Supplement Pre-Sub as needed

• Submit the original IDE and continue interacting with 

CDRH throughout the conduct of the EFS

23 Survey link: https://www.research.net/s/fdamdct
EFS Team

24

Names e-mail

Leaders

Andrew Farb, M.D.

Dorothy Abel

Andrew.Farb@fda.hhs.gov

Dorothy.Abel@fda.hhs.gov

DAGRID

Joel Anderson, Ph.D. 

Joy Samuels-Reid, M.D. 

Tejashri Purohit-Sheth, M.D.

Joel.Anderson@fda.hhs.gov

Joy.Samuels-Reid@fda.hhs.gov

Tejashri.Purohit-Sheth@fda.hhs.gov

DCD Carmen Gacchina Johnson, Ph.D. 

Anna Schroeder

Deborah Castillo, Ph.D.

Carmen.Gacchina@fda.hhs.gov

Anna.Schroeder@fda.hhs.gov

Deborah.Castillo@fda.hhs.gov

DNPMD

Viveca Livezey, M.D. 

Erin Keegan

Viveca.Livezey@fda.hhs.gov

Erin.Keegan@fda.hhs.gov

DOD

Dave McGurl

Jemin Dedania 

Casey Hanley, Ph.D.

David.McGurl@fda.hhs.gov

Jemin.Dedania@fda.hhs.gov

Casey.Hanley@fda.hhs.gov

DOED Tieuvi Nguyen, Ph.D.

Angelo Green, Ph.D., DABT

Tieuvi.Nguyen@fda.hhs.gov

Angelo.Green@fda.hhs.gov

DRGUD

Rebecca (Becky) Robinson, Ph.D. 

Veronique Li

Andrew Fu

Rebecca.Robinson@fda.hhs.gov

Veronique.Li@fda.hhs.gov

Andrew.Fu@fda.hhs.gov

DSD Long Chen, Ph.D. 

Betsy Ballard, M.D.

Long.Chen@fda.hhs.gov

Betsy.Ballard@fda.hhs.gov

OSEL Maureen Dreher, Ph.D.

Cristin Welle, Ph.D.

Maureen.Dreher@fda.hhs.gov

Cristin.Welle@fda.hhs.gov
Clinical Trials Program: 

Future Plans

• Continued monitoring of performance for IDEs in 

general and EFS IDEs

• Draft Benefit-Risk Guidance for IDEs

• Development of additional clinical trials training for 

CDRH review staff and external stakeholders

• Submission quality improvements

25

Survey link: https://www.research.net/s/fdamdct
Submission Quality

• Meeting our FY15 goals will require work by both FDA 

and IDE sponsors

• Many IDE submissions fail to “tell the sponsor’s 

story”

• Many others fail to provide basic information needed 

to support FDA’s IDE review

• Interaction with sponsor during IDE review can help 

resolve minor issues, but improvements in 

submission quality are a critical component as well

26

Survey link: https://www.research.net/s/fdamdct
Some major nonclinical 

reasons for IDE Deficiencies

• Device description

• Mechanical testing

• Biocompatibility

• Animal testing

27

Survey link: https://www.research.net/s/fdamdct
Types of questions that relate 

to submission quality

• Describe device components and materials

• Describe principle of operation and key characteristics

• Clarify version of device tested compared to version 

for clinical study

• Clarify what testing was done with rationale 

• Provide adequate description of test conditions, 

success criteria, and results

28

Survey link: https://www.research.net/s/fdamdct
Conclusions

• Strengthening the Clinical Trial Enterprise is a high 

priority for CDRH.

• We have made major progress in the past year.

• However, much work remains and future progress will 

be a joint effort between FDA and our external 

stakeholders.

29

Survey link: https://www.research.net/s/fdamdct
Important Guidance Documents

• FDA Decisions for IDE Clinical Investigations

– http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGui

dance/GuidanceDocuments/UCM279107.pdf

• IDEs for Early Feasibility Medical Device Clinical 

Studies

– http://www.fda.gov/downloads/medicaldevices/devicereg

ulationandguidance/guidancedocuments/ucm279103.pdf

• Design Considerations for Pivotal Clinical 

Investigations for Medical Devices

– http://www.fda.gov/downloads/MedicalDevices/DeviceReg

ulationandGuidance/GuidanceDocuments/UCM373766.pdf

• Evaluation of sex-specific data in medical device 

clinical studies

– http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGui

dance/GuidanceDocuments/UCM283707.pdf
Questions?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar 

Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: How to Market Your Device
How can CDRH best meet 

your needs for clinical trials 

training and communication?

Please fill out our short survey so that we may better 

understand your needs for education related to FDA 

requirements for clinical device trials.

Link: https://www.research.net/s/fdamdct

32