An Introduction to the Medical Device

User Fee Program: MDUFA V

Jeff Shuren, MD, JD

Director

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration
An Introduction to the Medical Device

User Fee Program: MDUFA V
MDUFA Program History

Authorized FDA to collect user fees 

for the review of premarket 

submissions. Enacted to provide 

additional resources to an under 

resourced medical device program.

MDUFA II - FDA 

Ammendments Act 

(FY2008-FY2012)

Reauthorized user fee collections 

and established tiered performance 

goals for 510(k) and PMA.

MDUFA III - FDASIA 

(FY2013-FY2017)

Reauthorized user fee collections 

and increased resources for medical 

device programs. Created more 

aggressive performance goals and 

introduced interim performance 

milestones (RTA, SI).

MDUFA IV - FDARA

(FY2018-FY2022)

Reauthorized user fee collections, 

increased resources, created more 

aggressive performance goals for 

510(k) and PMA, introduced new 

performance goals for De Novo and 

Pre-Sub. Support for NEST, digital 

health, ASCA Pilot, and patient 

engagement.

Reauthorizes user fee collections, 

increases resources, improves goals 

for PMA and 510(k) Total Time to 

Decision, Pre-Sub and De Novo,

introduces new goal structure with 

“add-on” payments, support global 

harmonization, creates TAP Pilot.

MDUFA V - FDASLA 

(FY2023-FY2027) 

MDUFA I - MDUFMA

(FY2003-FY2007)

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CDRH

Digital Health Center of 

Excellence (DHCoE)

Accreditation Scheme 

for Conformity 

Assessment (ASCA)

Patient Science and 

Engagement

Digital Transformation

Interactive Review and

Pre-Submission Review Goals

Real World 

Evidence (RWE)

Quality 

Management 

Total Product Life 

Cycle (TPLC) Advisory 

Program

(TAP Pilot)

International 

Harmonization

MDUFA V Supported Programs

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Enhanced Use of Consensus Standards: 

Accreditation Scheme for Conformity Assessment (ASCA) 

MDUFA V Commitments

• MDUFA IV pilot program intended to streamline conformity 

assessment aspects of device review and improve quality of 

testing

• Will transition from a pilot to a permanent program during 

MDUFA V

• Work with stakeholders to identify program enhancements and 

expansion criteria

• Provide training to FDA staff, industry, accreditation bodies and 

testing labs

• Track and report performance measures

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International Harmonization

MDUFA V Commitments

• Expand engagement in international harmonization and 

convergence efforts

• Create a mechanism for working with regulatory partners with 

whom we have confidentiality commitments

• Assess extent of CDRH implementation of IMDRF technical 

documents

• Support creation of a forum to identify opportunities for 

regulators to leverage one another’s approaches to decision 

making

• Participate in outreach activities to other regulators that 

encourage harmonization

• Issue a draft strategic plan in FY23, begin annual assessments in 

FY24

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Patient Science and Engagement 

Program in CDRH

Voice of Patients

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CDRH’s Journey Incorporating

Patient Perspectives

Patient Preference 

Initiative 

(2012)

Partner with 

Patients Strategic 

Priority 

(2016-17)

Patient Science and 

Engagement (PSE) 

Program 

MDUFA IV 

(FY18-22)

PSE Expansion and 

Integration 

MDUFA V

(FY23-27)

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Patient Science and Engagement

MDUFA V Commitments

• Facilitate patient engagement through patient-friendly educational 

content

• Explore ways to advance health equity by incorporating data and 

perspectives from diverse patients

• Expand patient science review expertise and capacity

• Improve regulatory predictability and impact of patient science, 

including new research case examples

• Hold public meeting on patient-generated health data (PGHD) for 

collecting clinical outcome assessment (COA) data and for remote 

clinical trials

• Issue guidance on incorporating COAs into premarket studies and 

update patient preference information (PPI) guidance

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Real-World Evidence (RWE) 

Program in CDRH

Assess Technology When Used in Clinical 

Practice

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RWE: 2012 to Current State

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NEST - Infrastructure

FDA

Customers

Payors Industry Professional 

Societies 

Academia

Providers 

Patients 

NEST Coordinating Center

Action AC 2 AC 3

Common Data Model

Datavant DC 2 DC 3

Data Platforms and Sources

+ Commercially Available Data Sources 12
Real World Evidence

MDUFA V Commitments

• Expand or develop RWE methods and policies for premarket 

submissions

• Update 2017 RWE Guidance

• Continue RWE training of review staff

• Transparent program updates, user-fee accounting

• Option for continued support for the National Evaluation System 

for Health Technology (NEST)

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Digital Health Program

in CDRH

Advance Innovation

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CDRH’s Digital Health Journey

In early days of digital health, CDRH developed changes to its approach to and policy for digital health, 

and we built on that over time.

The Mobile Medical 

Applications guidance 

clarified that FDA did 

not intend to regulate 

every health-related 

app, and take a 

platform-independent 

approach.

Mobile Medical 

Applications

2013

The 21st Century Cures 

Act took our approach 

to digital health and 

built much of it into 

law.

21st Century Cures 

Act

20XX

MDUFA IV helped us 

expand our Digital 

Health capabilities and 

supported the creation 

of CDRH’s Digital 

Health Center of 

Excellence.

MDUFA IV

2017-2022

Through the “Pre-Cert” 

Pilot Program, we 

explored innovative 

tailored total product 

lifecycle approaches to 

medical device 

software.

Digital Health 

Precertification Pilot

2017-2022

Several guidance 

documents were 

updated or newly 

published as final to 

further implement the 

Cures Act, including the 

function based 

approach.

Final Guidance 

Implementing 

“Cures”

We led stakeholder 

engagement, shared a 

discussion paper, and 

an AI/ML action plan to 

further a total product 

lifecycle regulatory 

framework.

AI/ML Initiatives

2016 20XX 20XX 2019-2022 2019+

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CDRH’s Digital Health Center of Excellence

continues momentum in digital health to support FDA’s public health mission.

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Digital Health

MDUFA V Commitments

• Build software and digital health technical 

expertise

• Streamline and align review with software 

lifecycles

• Participate in international harmonization 

and convergence

• Finalize guidance for device software 

functions

• Publish draft guidance on evaluating 

change control plans

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Total Product Lifecycle Advisory 

Program (TAP)

Engagement with Device Developers

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Limits of Current Developer

Engagement Opportunities

Idea

Planning,

Testing, 

Clinical Study 

FDA 

Marketing 

Decision

Limited 

Adoption; 

Generating 

Data  Payors

Coding and

Coverage 

Decisions

Reimbursement 

and 

Widespread 

Adoption

X X

→ No single stakeholder has 

ownership of total process

→ It’s not laying blame; it’s just 

the way the system evolved

FDA Providers Payors Patients

X

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TAP Pilot

Long-term Vision | Help spur more rapid development and more 

rapid and widespread patient access to safe, effective, high-quality 

medical devices of public health importance.

Voluntary Pilot in MDUFA V

• Provide earlier and more frequent interactions with FDA, as well 

as facilitate coordination of earlier and more strategic 

stakeholder input, with a focus on Breakthrough and STeP 

devices.

• Begin with “soft launch” of up to 15 products in one CDRH OHT 

in FY 2023, and expand to enroll up to 325 products across 

multiple OHTs by end of MDUFA V.

• FDA will conduct an assessment of the TAP Pilot using an 

independent third party and include a participant survey and 

quantitative and qualitative success metrics.

Build upon lessons learned from FDA’s Breakthrough Devices 

Program and COVID-19 pandemic response 20
TAP Pilot: Intended Impact

A shorter, happier journey

Idea

Planning,

Testing, 

Clinical Study 

FDA Marketing 

Decision

Limited 

Adoption; 

Generating Data 

 Payors

Coding and

Coverage 

Decisions

Reimbursement 

and Widespread 

Adoption

Requirements and preferences

FDA

Payors Providers

Patients

FDA and Stakeholder Expertise

Many touch points early on

Better evidence 

strategy for faster 

commercialization Patient access 

to high quality, 

innovative, 

safe, and effective 

medical devices

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TAP Pilot

Implementation

• Starting w/OHT-2 (Cardiovascular)

• 15 companies with new Breakthrough 

Designation

• Teleconference within 14 days (90%)

• Biocompatibility/Sterility written feedback 

within 21 days (90%)

• Written feedback for other requests within 40 

days (90%)

Assessment

• Independent third party

• Quantitative metrics

• Time from BDD/STeP to Marketing 

Submission

• Time from Submission to Marketing 

Authorization

• Requests for additional info during review

• Company satisfaction of interactions w/FDA 

and non-FDA Stakeholders

FY23 – Soft Launch

≤15 devices

One OHT (OHT2)

FY24

≤45 additional 

devices 

(60 total)

≥2 OHTs

FY25

≤65 additional 

devices 

(125 total)

≥4 OHTs

FY26

≤100 additional 

devices 

(225 total)

option to expand 

to more OHTs*

FY27

≤100 additional 

devices 

(325 total)

option to expand 

to more OHTs*

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Acronym Glossary

AI/ML Artificial Intelligence/Machine Learning OCEA Office of Clinical Evidence and Analysis

ASCA Accreditation Scheme for Conformity Assessment OHT Office of Health Technology

BDD Breakthrough Device Designation OPEQ Office of Product Evaluation and Quality

COA Clinical Outcome Assessment OUD Opioid Use Disorder

DHCoE Digital Health Center of Excellence PCCP Predetermined Change Control Plan

FDARA Food and Drug Administration Reauthorization Act PGHD Patient-Generated Health Data

FDASIA Food and Drug Administration Safety and Innovation Act PMA Premarket Approval

FDASLA Food and Drug Administration Safety and Landmark 

Advancements Act PPI Patient Preference Information

FY Fiscal Year PSE Patient Science and Engagement

IMDRF International Medical Device Regulators Forum RTA Refuse to Accept

MDUFA Medical Device User Fee Amendment RWE Real-World Evidence

MDUFMA Medical Device User Fee and Modernization Act SI Substantive Interaction

NEST National Evaluation System for health Technology STeP Safer Technologies Program

NESTcc National Evaluation System for health Technology Coordinating 

Center TAP Total Product Lifecycle Advisory Program 23
Summary from CDRH

Lessons learned from previous cycles have 

informed the size and scope of today’s 

MDUFA program

User fees collected as part of the MDUFA V 

legislation will allow us to meet the needs 

of our customers while driving innovation

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Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 200 modules - videos, webinars, presentations, software-based “how to” 

modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information across the device total product life cycle: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

 Phone: 1-800-638-2041 or (301) 796-7100 (Live Agents 9 am – 12:30 pm; 1 – 4: 

30 pm ET)

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