The FDA's Medical Device Development Tools (MDDT) program is intended to facilitate device development and timely evaluation of medical devices, and promote innovation, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.

The MDDT program is a way for the FDA to qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices. Tools such as biomarker tests, clinician-reported outcome measures, patient-reported outcome measures, or non-clinical assessment models such as animal or computational models, and digital health technologies like sensors or wearables, play an important role in helping the FDA understand how medical devices work, in terms of safety, effectiveness, and other aspects of performance.

The voluntary MDDT program helps to improve predictability and efficiency in device development and regulatory review. When deciding whether to qualify a tool, the FDA evaluates the tool and available supporting evidence to determine whether it can be used as intended to produce scientifically plausible measurements within a specified context of use. Medical device sponsors can use qualified tools and be sure they will be accepted by the FDA without the need to reconfirm the suitability and utility of the tool within the same context of use.

On this page:

• Qualified Medical Device Development Tools (MDDTs)
• Why the FDA Developed the MDDT Qualification Process
• MDDT Qualification and the Qualification Process
• How to Participate in the MDDT Program
• Regulatory Science Tools and MDDTs
• Contact

Qualified Medical Device Development Tools (MDDTs)

The FDA has qualified MDDTs for cardiovascular, neurology, plastic surgery, automated insulin dosing, and imaging devices, as well as crosscutting tools for active implanted medical devices and cybersecurity.

The following table lists MDDTs qualified by the FDA, along with a Summary of Evidence and Basis of Qualification (SEBQ) for the tool. This summary includes:

• A brief description of the tool
• The qualified context of use
• A general summary of evidence to support qualification
• A brief assessment of the advantages and disadvantages of using the tool
• Information on how to contact the tool developer about accessing the tool

Medical device sponsors submitting a marketing application that relies on a qualified MDDT may include the MDDT submission number in the cover letter or the FDA CDRH Premarket Review Submission Cover Sheet form 3514 (Section F or J). The MDDT submission number for each qualified tool can be found in the SEBQ.

Tool (Link to SEBQ)	Product Area(s)	MDDT Category	Date Qualified
Virtual MRI Safety Evaluations of Medical Devices	Imaging	Non-clinical Assessment Model	11/16/2021
Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS)	Ophthalmology	Clinical Outcome Assessment	06/17/2021
IMAnalytics with MRIxViP1.5T/3.0T And BCLib	Active implanted medical devices (AIMDs)	Nonclinical Assessment Model	05/20/2021
Rubric for Applying CVSS to Medical Devices	Cybersecurity	Nonclinical Assessment Model	10/20/2020
BREAST-Q Reconstruction Module	Plastic Surgery	Clinical Outcome Assessment	08/20/2020
Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) Questionnaires	Automated Insulin Dosing (AID)	Clinical Outcome Assessment	06/24/2020
Tissue Mimicking Material (TMM) for Preclinical Acoustic Performance Characterization of High Intensity Therapeutic Ultrasound (HITU) Devices	Imaging	Nonclinical Assessment Model	07/10/2019
OSIRIX CDE Software Module	Neurology	Biomarker Test	03/12/2019
Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Cardiology	Clinical Outcome Assessment	03/19/2018
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Cardiology	Clinical Outcome Assessment	10/19/2017

Context of Use

The context of use statement is a description of the way the tool is to be used and the purpose of its use in the medical device development, evaluation, and regulatory review process in a particular product area. An MDDT is qualified for a specific context of use. The qualified context of use defines the boundaries within which the available data adequately justify use of the MDDT. As data are obtained from additional studies over time, tool developers may submit the supplementary data to the FDA to potentially expand upon the qualified context of use.

More information about the context of use is in the final guidance, Qualification of Medical Device Development Tools.

MDDT Categories

The FDA recognizes three categories of MDDTs, which can be distinguished primarily by how the tool measures the relevant parameters:

• Clinical Outcome Assessment (COA) can be made through report by a clinician, a patient, a non-clinician observer or through a performance-based assessment. It can be used to inform patient eligibility or clinical study endpoints. For details on COAs, see Clinical Outcome Assessments (COAs) in Medical Device Decision Making.
• Biomarker Test (BT) is a test or instrument used to detect or measure a biomarker. A biomarker test can be used to assess risk, or identify safety concerns, or predict treatment outcomes in patients.
• Nonclinical Assessment Model (NAM) is a non-clinical test model or method that measures or predicts device function or in vivo device performance. It can be a computational or animal model used to:
  • Measure or predict a parameter of interest
  • Reduce or replace animal testing
  • Reduce test duration or sample size.

More information about the categories of MDDT is in the final guidance, Qualification of Medical Device Development Tools.

Why the FDA Developed the MDDT Qualification Process

Prior to the development of the MDDT Qualification process, the FDA evaluated tools on a case-by-case basis for each medical device submission.

The FDA created the voluntary MDDT program to:

• Advance innovation, by focusing on the science needed to evaluate novel technologies.
• Increase predictability for medical device sponsors, by making it clear FDA accepts assessments from an MDDT in support of demonstrating safety, effectiveness, or performance of a medical device, when used within the qualified context of use.
• Improve efficiency and transparency, by facilitating use of validated and qualified tools across multiple medical device submissions and manufacturers.
• Encourage collaboration in developing tools and supporting evidence, to pool resources and drive increased use and acceptance of qualified tools.

MDDT Qualification and the Qualification Process

MDDT qualification is a regulatory conclusion that within the stated context of use, the MDDT methodology is a well-defined and reliable measure of a specific concept and has a specific interpretation and application in device development and regulatory decision-making.

The qualification process consists of two phases: The Proposal Phase and the Qualification Phase.

Proposal Phase

The goal of the proposal phase is to determine if the MDDT is suitable for qualification through the MDDT program and to identify the performance criteria that will be used to assess qualification. In this phase, the FDA asks submitters to provide information about the tool and the data collection plan, including the context of use. The FDA developed an optional Qualification Plan template to help the submitter provide the key elements they need to include in the qualification process.

Those interested in seeking acceptance into the MDDT program should submit a complete proposal package.

To submit a proposal, download and follow the instructions to format the cover sheet and qualification plan contents. If you have any questions, send email to [email protected].

Download the Qualification Plan Template

During this phase, the FDA can provide feedback to submitters on their plan to collect evidence to support qualification of the tool.

Qualification Phase

The goal of this phase is to determine whether, for a specific context of use, the tool is qualified based on evidence and justifications provided. In this phase, the FDA asks submitters to provide the data collected according to the qualification plan developed in the proposal phase as a full qualification package to qualify the MDDT. A submitter enters this phase after receiving notification from the FDA that the MDDT is accepted into the Qualification Program.

The FDA developed a Summary of Evidence and Basis of Qualification (SEBQ) template that is intended to present an objective and balanced summary of the scientific evidence that served as the basis of the decision to qualify an MDDT. The FDA intends to publicly disclose the SEBQ on the MDDT website if the FDA qualifies the tool.

Download the SEBQ Template

Phase	Goal	Information Submitted
Proposal Phase	Determine if the MDDT is suitable for qualification through the MDDT program.	Submit a complete Qualification Plan for collecting and gathering evidence for qualification of the tool, a description of the MDDT, and context of use.
Qualification Phase	Determine whether, for a specific context of use, the tool is qualified based on the evidence and justifications provided.	Submit the data collected according to the Qualification Plan as part of the Full Qualification Package, which the FDA reviews for the qualification decision.

For more information about the process for qualifying MDDTs, see the final guidance, Qualification of Medical Device Development Tools.

How to Participate in the MDDT Program

Any tool developer, medical device sponsor, or others such as research organizations and academia can voluntarily submit a proposal. The program aims to provide MDDT developers and medical device sponsors with a mechanism for discussing early concepts about a tool, fostering collaboration on tool development, and facilitating increased adoption and use of qualified tools.

Fees: There are no fees associated with submitting a tool for qualification.

Submitting a Proposal as an eCopy: Proposals should be submitted as an eCopy in the form of a CD, DVD, or flash drive and should be sent to the CDRH Document Control Center at this address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

The eCopy should meet the technical standards outlined in eCopy Program for Medical Device Submissions.

Questions: If you have any questions, contact us at [email protected]. You may also want to refer to this webinar about the qualification of MDDT tools:

• Webinar - CDRH Final Guidance: Qualification of Medical Device Development Tools - August 24, 2017

Regulatory Science Tools and MDDTs

The Catalog of Regulatory Science Tools provides a peer-reviewed resource for companies to use where standards and MDDTs do not yet exist.

The tools reduce the need for device developers to design ad-hoc test methods and allow them to focus their limited resources on how well their new product works.

It is therefore of great benefit to both innovators and the FDA to use a common set of methodologies wherever possible. Over time, the FDA would expect the most useful regulatory science tools to progress through the qualification process to become fully fledged MDDTs.

Contact

If you have questions about the MDDT Program, email [email protected].