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Today’s Topic: 

Qualification of Medical Device Development Tools (MDDTs) 

September 12, 2023
Qualification of Medical Device 

Development Tools, Guidance

Center for Devices and Radiological Health 

U.S. Food and Drug Administration

Jessica Mavadia - Shukla, Ph.D. 

Director, Medical Device Development Tools 

Division of All Hazards Response, Science and Strategic Partnerships 

Office of Strategic Partnerships and Technology Innovation
Guidance

• Qualification of Medical Device Development Tools, Guidance for Industry, 

Tool Developers, and Food and Drug Administration Staff, issued on July 17, 

2023 

– www.fda.gov/regulatory-information/search-fda-guidancedocuments/qualification-medical-device-development-tools

– www.federalregister.gov/documents/2021/11/04/2021-24061/content-ofpremarket-submissions-for-device-software-functions-draft-guidance-forindustry-and-food

• Medical Device Development Tools (MDDT) Webpage 

– www.fda.gov/medical-devices/medical-device-development-tools-mddt

3
MDDT Guidance

• Streamlines framework and process for qualification of 

an MDDT 

• Does not discuss individual MDDT submissions 

• Does not address specific evidentiary or performance 

expectations of an MDDT submission

4
Learning Objectives

• Define medical device development tools (MDDTs) 

• Discuss MDDT qualification and its benefits 

• Describe the qualification decision framework 

• Discuss other regulatory considerations and related 

recommendations 

• Discuss how to submit an MDDT proposal package

5
MDDT Program

• Voluntary 

• Reduces regulatory burden in evaluating medical 

devices 

• Facilitates development and timely evaluation of 

medical devices 

• Supports regulatory submissions and decision - making 

• Tool submitters may be a person, group, consortium, 

or organization (including the federal government)

6
What is an MDDT?

• Method, material, or measurement 

– to assess safety, effectiveness, or performance of a 

medical device 

• Scientifically substantiated 

– May be qualified for use in device evaluation and 

support regulatory decision-making

7
Examples of MDDTs

Non-clinical Assessment Model

Non-clinical test model or 

method that measures or 

predicts parameters of interest 

in regard to safety, effectiveness, 

or device performance

Biomarker Test

Test or instrument used to detect or 

measure a biomarker. Biomarkers 

are a defined characteristic 

measured as an indicator of normal 

biological processes, pathogenic 

processes, or biological responses to 

an exposure or intervention, 

including therapeutic interventions

Clinical Outcome Assessment

Assessment of a clinical 

outcome reported by a 

clinician, a patient, a nonclinician observer or through a 

performance-based 

assessment.

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What is MDDT Qualification?

• A conclusion, based on CDRH review of the MDDT 

Qualification Package 

• Signifies that the MDDT can be relied upon to facilitate 

regulatory decision making when used according to 

qualified context of use

9
What is MDDT Qualification?

• CDRH reviewers should accept MDDT for qualified 

context of use 

– Without need to reconfirm suitability and utility of MDDT 

when used in the regulatory submission 

• Developers are encouraged to make their qualified 

MDDTs publicly available

10
Benefits of MDDT Qualification

Patients

Medical Device 

Manufacturers

Tool Developers Regulators 

FDA, CDRH 

Regulatory 

Scientists

• Bridges gaps between 

research and development 

– Innovation 

– Collaboration 

• Can be applied to multiple 

device submissions 

– Efficiency in CDRH Review 

– Minimizes uncertainty in 

review process 

• Reduces individual resource 

expenditure

11
Key Components of MDDT 

Qualification Framework

MDDT Description

Context of Use

Regulatory Utility

Strength of Evidence

Assessment of Advantages and Limitations 

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Context of Use

• Statement that fully, clearly describes the way to use 

the MDDT and its medical device development - related 

purpose 

• A complete context of use should address: 

– Output/measure/assessment from MDDT 

– Role of MDDT in regulatory evaluation (such as for use in 

clinical studies) 

– Phase of development where MDDT may be used (such as 

design evaluation, animal testing, or early clinical studies)

13
Types of Evidence 

to Support Qualification 

• Design Verification 

• Simulation Results from Computational Models 

• Bench or Animal Performance Data (such as full 

test reports and protocols)

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Types of Evidence 

to Support Qualification 

• Clinical Data (full test reports and protocols, all 

appropriate pre - specified statistical analyses to 

demonstrate relationship between tool and 

context of use) 

• Human Factors Testing

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Assessment of 

Advantages and Limitations

• For proposed context of use and plan for evidence generation, 

identify advantages and limitations 

• Advantages 

– Should highlight impact of tool use in support of regulatory decision 

making 

• Limitations 

– Should accurately detail conditions under which tool should not be used 

or may not provide meaningful assessment of safety, effectiveness, or 

performance of a medical device 

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Qualification Process

Proposal Phase Qualification Phase 

1) Determine suitability of MDDT 

based on ability to facilitate 

regulatory decision making. 

2) Review Qualification Plan with 

performance criteria and plan for 

collecting and gathering evidence in 

support of proposed and context of 

use.

1) Evaluate strength of evidence in 

Qualification Package to determine 

whether evidence meets the 

performance criteria and supports the 

Qualification Plan for proposed 

context of use.

2) Qualify tool if the evidence supports 

the proposed context of use.

FDA only intends to qualify tools where FDA can make public certain high - level information about the 

existence of qualified tools and their utility

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Key Content to Include in Proposal Phase

MDDT Description Concept of Interest/Description of principle

Method and mode of measurement

Context of Use 

Statement

Use within regulatory submission

Specific output(s), measure(s), endpoints, timing of assessments, etc.

Performance Performance characteristics of measurement outputs

Criteria Measurement properties (reliability, meaningful change, etc.)

Scientific justification for strength of evidence collected to support qualification

Qualification Plan Methods and Performance data to be collected

Design verification and validation/validity evidence to be collected

Relationship between measurement outputs/validity evidence to context of use

Assessment of 

Advantages and 

Limitations

Advantages should highlight impact of tool use on regulatory decision making

Limitations should highlight conditions under which tool cannot provide a 

meaningful assessment 

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Key Content to Include in Qualification Phase

Contents of Proposal including: 

• Tool description 

• Context of use statement 

• Performance criteria 

• Qualification plan

Proposal

Tool Evidence Evidence

Clinical Outcome Assessment (COA) Dossier

Assessment of 

Advantages and 

Limitations

Advantages should highlight impact of tool use on regulatory decision 

making

Limitations should highlight conditions under which tool cannot 

provide a meaningful assessment 

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Regulatory Considerations and 

Related Recommendations

• Some MDDTs may meet definition of a device in section 201(h) 

of the Federal Food, Drug, and Cosmetic Act 

– impacted by how MDDT is intended for use 

• Unlikely a device if: 

– only for use in device development or evaluation 

– not for use in diagnosing or treating patients or study subjects

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Regulatory Considerations and 

Related Recommendations

• Likely a device if: 

– MDDT is intended for use in diagnosing or treating, or aiding in the 

diagnosis or treatment of subjects in a clinical study 

• Likely a device but not an MDDT if: 

– a product intended for use in diagnosing or treating, or aiding in 

diagnosis or treatment of patients in clinical settings outside clinical 

studies

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Regulatory Considerations and 

Related Recommendations

• MDDT qualification versus clearance or approval of medical 

device 

– Type of evidence needed to support MDDT qualification is not the type of 

evidence needed to support marketing authorization for a medical device 

• MDDT qualification versus consensus standards and devicespecific FDA guidance 

– MDDTs are not meant to replace standards development and recognition 

process 

– MDDTs are not meant to replace device-specific FDA guidance

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Summary of Evidence and 

Basis of Qualification (SEBQ)

• SEBQ includes: 

– Brief description of tool and principle of operation 

– Qualified context of use 

– Summary of evidence to support qualification 

– Assessment of advantages and limitations 

– Contact information for tool developer 

• SEBQ does not include proprietary information

23
MDDT Proposal Submission Process

• Any tool developer, medical device sponsor, or others, 

such as research organizations and academia can 

voluntarily submit a proposal 

• No Fees 

• MDDT Proposal Submission Content 

– www.fda.gov/medical-devices/medical-device-development-toolsmddt/medical-device-development-tool-mddt-proposal-submissioncontent

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MDDT Proposal Submission Process

• We recommend you use CDRH Premarket Review Submission 

Cover Sheet 

– Facilitates correct login and prompt routing to appropriate CDRH review 

group 

• Identify requests as an “MDDT” in the cover letter 

• MDDT proposals and qualification packages are tracked with a 

universal tracking number (UTN) 

– Previously were Informational Meeting Q - Submissions 

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MDDT Proposal Submission Process

• Submission Methods: 

– Electronically through the CDRH Customer Collaboration Portal 

• www.fda.gov/medical-devices/industry-medical-devices/send-andtrack-medical-device-premarket-submissions-online-cdrh-portal

– Mail to the CDRH Document Control Center 

• www.fda.gov/medical-devices/how-study-and-market-yourdevice/ecopy-medical-device-submissions

• Email questions to MDDT@fda.hhs.gov

26
Summary

• MDDT Program is voluntary pathway to qualify regulatory 

science tools. 

• MDDTs are tools that assess safety, effectiveness or 

performance of a medical device. 

• MDDTs are not intended to replace standards 

development and recognition or device specific guidance. 

• FDA intends to publicly disclose SEBQ for qualified tools. 

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Additional Panelists

Brittany Caldwell, PhD 

Assistant Director 

Partnerships to Advance Innovation and 

Regulatory Science 

Division of All Hazards Response, Science and 

Strategic Partnerships 

Office of Strategic Partnerships

Lisa Simone, PhD 

Senior Health Scientist 

All Hazards Readiness 

Response & Cybersecurity 

Division of All Hazards Response, Science and 

Strategic Partnerships 

Office of Strategic Partnerships

Center for Devices and Radiological Health 

U.S. Food and Drug Administration

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Let’s Take Your Questions

• To Ask a Question: 

1. Raise your hand in Zoom 

2. Moderator will announce your name and invite you to ask your question 

3. Unmute yourself when prompted in Zoom to ask your question 

• When Asking a Question: 

• Ask one question only 

• Keep question short 

• No questions about specific submissions 

• After Question is Answered: 

• Mute yourself and lower your hand 

• If you have more questions - raise your hand again

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Thanks for Joining Today!

• Presentation and Transcript will be 

available at CDRH Learn 

• www.fda.gov/Training/CDRHLearn

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webinar

• Email: DICE@fda.hhs.gov

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