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Office of Device Evaluation:

Current Status and Future

Direction

John Sheets, Ph.D.Director, Office of Device Evaluation

slides courtesy of Jeff Shuren, MD, JDCenter for Devices and Radiological Health

U.S. Food and Drug Administration

www.fda.gov

Public Health Challenge

• U.S. regulatory standard

• High bar, imposes costs

• U.S. less attractive for innovators

• Delays patient access

Solution - reduce the time

and cost of the total product

life cycle…

without compromising the reasonable assurance of safety and effectiveness standard

Vision“Patients in the U.S.

have access to high-

quality, safe and

effective medical

devices of public health

importance first in the

world.”

www.fda.gov

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CDRH Strategic Priorities

2014-2015 2016-2017

Strengthen the Clinical Trial Enterprise

Establish a National Evaluation System for

Medical Devices (NEST)

Strike the Right Balance Between Premarket & Postmarket Data

Collection

Partner with Patients

Provide Excellent Customer Service

Promote a Culture of Quality and Organizational

Excellence

www.fda.gov

4

2014-2015 Strategic Priorities

Noteworthy Results

• Established Clinical Trials Program to increase early feasibility studies in the US

• Implemented Expedited Access Pathway for breakthrough devices 23 EAPs granted (11 IDEs)

• Reduced median time to IDE approval to 30 days

• Customer service training achieved 90% customer satisfaction (real-time survey)

• Approved highest number of novel devices (79 CY2015) since 2003

www.fda.gov

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Flexible Regulatory ParadigmsApplied Across the Total Product Life Cycle

Patient-Centered, TPLC ApproachBenefit-Risk Tradeoffs

Science of

Patient Input

Premarket-

Postmarket

Balance

Evidence Generation

IDE Benefit-Risk Determination

Framework Draft Guidance (2015)

Expedited Access Pathway Program (2015)

Patient Preference Information Guidance

(2016)

Early Feasibility Study Paradigm Guidance (2013)

Balancing Premarket and Postmarket Data Collection Guidance

(2015)

Medical Device Innovation Consortium

(MDIC) Patient Centered Benefit-Risk Project

PMA, De Novo Benefit-Risk Determination Framework Guidance (2012)

Postmarket Benefit-Risk Draft Guidance (2016)

CDRH Vision

www.fda.gov

Clinical Trials Regulatory Science

Real-World Evidence

MDDT Pilot Program

MDDT Draft Guidance

(2015)

Unique Device

Identification Final Rule

(2013)

RWE Draft Guidance

(2016)

MDICNEST

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The Value Proposition

Patients & Clinicians • More timely access• Safer, more effective devices• Better information

Hospitals & Integrated Health Systems • Improved device quality• Reliable assurances of safety• Relief from multiple reporting

Payers • High-quality evidence

www.fda.gov

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The Value Proposition

for Manufacturers

High-quality evidence, lower cost, less time • Support premarket decisions • Support payer reimbursement & coverage decisions• Meet or reduce postmarket study and AE reporting

Strong assurance that postmarket data will be collected• Support responsible shift premarket to postmarket• For some devices with high public health value

Timely & informative evaluation of device modifications • Obtained in the course of routine data collection• May obviate premarket review of modifications

www.fda.gov

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Key Features of NEST

Business Model • Independent Coordinating Center & Governing Board • Standardized Core Data Elements & Advanced

Analytics• Data Use Agreements (Condition of Participation) • Market-driven, Collective Buying Power• Private and Public Sector Base Funding• Users Pay for Access & Data Analysis

Success → Demonstrate ROI• Reduce Time & Cost, Increase Use & Value of RWE• Meet the Needs of Ecosystem Stakeholders• Administrative Fees Provide Sustainability & Growth

www.fda.gov

Proof of Concept

Premarket Examples

Registry Data to Support Approval

• Expanded Indication Transcatheter Aortic Valve

• New Indication Drug-coated Balloon (In-stent Restenosis)

• Control Arm in Pivotal Studies

– LVAD

– Stent Graft

– Surgical Mesh

www.fda.gov 9

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Proof of Concept

Postmarket Examples

Post-approval study of TEVAR devices – enrolled patients 2x faster

Nesting of required postmarket studies in registries– 40% to 60% cost savings

Pilot of registry data in lieu of MDRs for on-label AEs– Early results look promising

www.fda.gov

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NEST

Recent Accomplishments

• MDIC selected as the Coordinating Center

• Granting $3M to the Coordinating Center, $1M for pilots

• Issued Use of Real-World Evidence Draft Guidance

• Data use agreements with 14 registries to access 22 million patient records; more in the works

• MDUFA 4

www.fda.gov

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Partner with Patients

Recent Accomplishments

• Patient Preference Information Guidance issued

• Collaborative PPI research in ophthalmology, prosthetic limbs, women’s health, prostate cancer

• 51% of PMA, de novo, and HDE decisions include a public summary of patient perspective data considered

• As of September 30, 2016, 63% of CDRH staff have interacted with patients as part of their job duties

• MDUFA 4

www.fda.gov

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Adopt a Culture of Quality

Case for Quality

• Foster market competition around quality and safety through MDIC

• Establish common framework for value-based quality among industry, FDA, purchasers, and users

• Identify best practices, explore regulatory and market incentives

• Create a Maturity Model and metrics for quality system performance, product quality, and corporate culture

• Develop voluntary program to recognize independent evaluation of product and manufacturing quality

www.fda.gov

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Adopt a Culture of QualityCDRH Quality Management Program

• Quality Management Framework 2013

• Recommendations of the MDUFA 3 independent assessment 2015

• Continuous improvement and customer service 2015

• Management review procedures 2016

• ASQ Enterprise Membership and Training 2016

• Document Control system 2017

• Audit & quality training 2017

• MDUFA 4

www.fda.gov

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Streamlining the Pathway from

Approval to Payment

Parallel Review with CMS

– Foundation Medicine’s FoundationOne, incorporating multiple companion diagnostics for cancer

– Published Oct 24, 2016 Program for Parallel Review of Medical Devices, Parallel-Review@fda.hhs.gov or Murray Sheldon, 301-796-5443

Private Payers

– Opportunity to participate in pre-submission meetings

www.fda.gov

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International Medical Device

Regulators Forum

• Unique Device Identification

• National Competent Authority Report Exchange Program

• Regulated Products Submission

• Adverse Event Reporting

• Device Registries

• Software as a Medical Device

• Medical Device Single Audit Program

• Premarket Review

www.fda.gov

- May require voluntary reliance on conformance with safety & performance principles or standards for 510(k)s and the voluntary participation in a progressive approval pathway for PMAs and de novos.

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Achieving Our VisionBenefit, Safety and Timely Access

• Early Feasibility Studies for Transcatheter Mitral Valve Replacement Devices: on par with other countries

• Edwards Lifesciences SAPIEN XT/3 for Intermediate Risk Patients: reduced the gap from 4+ years to 18 days, “automatic” CMS coverage

• Medtronic MiniMed 670G hybrid closed loop system (“artificial pancreas” for type 1 diabetes patients): First in the world

www.fda.gov

Learning Medical Device Ecosystem

Postmarket

Surveillance

National

Evaluation

System (NEST)

Real-World

Evidence

TIME TO MARKET

Expedited

Access

Pathway

Premarket

Review

Pre

ma

rke

t De

cis

ion

Benefit -Risk

INFORMATION FLOW

“Safety Net”

EVOLUTION OF BENEFIT–RISK EVIDENCE

Total Product Life Cycle (TPLC)

Progressive

Approval,

Safety and

Performance

Benefit-Risk

INTERNATIONAL HARMONIZATION

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Patient Access

NEST

Clinical

Research

Incorporated

Into Routine

Clinical

Practice

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CHALLENGES

www.fda.gov

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Medical Device Manufacturing

Companies by Number of

Employees 2014

Source: Dun and Bradstreet, Inc. Date: 2014

75%

12%9%3%

.7%

<10

20 to 99

10 to 19

100 to 499

>500

www.fda.gov

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1.4 Million MDRs RECEIVED IN 2015

2490CLASS I,II, AND III RECALLS IN 2015

Interesting Facts

175,000DIFFERENT

DEVICES ON THE U.S. MARKET

18,716MEDICAL DEVICE

MANUFACTURURES of which 8,995

ARE U.S. BASED

22,000PREMARKET SUBMISSIONS

ARE RECEIVED BY CDRH ANNUALLY

50%OF IMPORTED FDA-

REGULATED PRODUCTS ARE CDRH PRODUCTS

25,303MEDICAL DEVICE

FACILITIES OF WHICH 13,363

ARE IN THE U.S.

www.fda.gov

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Importation of FDA-Regulated

Products by Fiscal Year

0

5,000,000

10,000,000

15,000,000

20,000,000

25,000,000

30,000,000

35,000,000

40,000,000

2009 2010 2011 2012 2013 2014 2015

CVM CTP CFSAN CDRH CDER CBER

www.fda.gov

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Current CDRH IT Systems

www.fda.gov

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Our Current Situation

OIMT Bill (Initial FY16 Allocation)

CDRH IT O&M (Program Support)

CDRH IT Enhancements (Add’l Needs)

$36,599,417

$14,000,000

$12,500,000

$63Min FY16

www.fda.gov

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27www.fda.gov

Hiring

MedicineScience

QualityManagement

ProjectManagement

Engineering

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Thank You

www.fda.gov