The FDA's Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use.
The context of use depends on:
- the tool or product area in which the tool is proposed for qualification
- the specific output or measure from the MDDT
- the role of the MDDT (for example, for clinical uses, including the study population or disease characteristics, as well as specific use-diagnosis, patient selection, and study endpoints), and
- the phases of medical device development during which the MDDT or tool measurements can be used (for example, design evaluation or early clinical study).
More information about the context of use is in the final guidance on Medical Device Development Tools.
The MDDT program promotes innovation in medical device development and regulatory science to help bridge the gap between research of medical devices and the delivery of devices to patients.
The FDA has defined three categories of MDDT:
- Clinical outcome assessment: measures of how a patient feels or functions. These could be patient-reported or clinician-reported rating scales like the NIH stroke scale, measures based on clinical decision-making, observer-reported outcomes such as from a parent or caregiver, or performance outcome measures, such as measures of gait speed or memory recall.
- Examples of tools that might be eligible for qualification include: patient reported outcome rating scales, such as those used to measure pain, improved mobility, symptom relief, function, or health status and heart failure-related hospitalization.
- Biomarker test: a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker).
- Examples of tools that might be eligible for qualification include: tests used as an aid in diagnosis, for patient selection, or as clinical study endpoints, such as instruments or methods for measuring blood pressure; or instruments or methods for measuring certain concentrations of serum proteins, such as an assay to detect the level of a specific hormone in a patient in order to determine enrollment eligibility for study population in a clinical trial.
- Nonclinical assessment model: a nonclinical test method or model (e.g. in vitro "bench," animal or computational model) that measures or predicts device function or performance in a living organism.
- Examples of tools that might be eligible for qualification include: models used to measure a parameter of interest or to substitute for another generally accepted test or measurement, such as computer modeling to assess conditions typically evaluated through human, animal or bench testing to evaluate a device instead of collecting data from human subjects; use of tissue and other material phantoms to evaluate imaging devices; or In vitro models to replace animal testing.
More information about the categories of MDDT is in the final guidance.
The goal of the voluntary MDDT program is to assess and refine the qualification process for tools used to develop and evaluate medical devices. The program aims to provide MDDT developers and medical device manufacturers with a mechanism for discussing early concepts about a tool, fostering collaboration on tool development, and potentially increasing adoption and use of the qualified tools.There are no fees associated with submitting a tool for qualification.
Any tool developer, medical device manufacturer, or others such as research organizations and academia can voluntarily submit a proposal as an eCopy. The eCopy should be in the form of a CD, flash drive, etc., and should be sent to the Document Mail Center at the following address:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
The eCopy should meet the technical standards outlined in Attachment 1 of the FDA guidance "eCopy Program for Medical Device Submissions."
To submit a proposal, download this Proposal Phase Template and follow the instructions to format the cover sheet and qualification plan contents. If you have any questions, please contact us at MDDT@fda.hhs.gov.
The voluntary qualification process consists of several phases described below.
The goal of the proposal phase is to determine if the MDDT is suitable for qualification through the MDDT program. Those interested in seeking qualification should submit a complete proposal package, including a description of the MDDT, and a justification for how the MDDT will help address a public health need.
Incubator phase (optional)
In certain instances CDRH may accept MDDTs with a high potential public health impact that are not fully developed. The goal of the incubator phase is for CDRH to work with submitters to foster the development of tools that have potential to significantly improve public health. CDRH will determine whether this phase is necessary.
Pre-Qualification phase (optional)
During the pre-qualification phase, CDRH can provide feedback to submitters on their plan to collect evidence to support qualification of the tool. CDRH will determine whether this phase is necessary.
The goal of the qualification phase is to determine whether, for a specific context of use, the tool is qualified based on the evidence and justifications provided.
More details about the phases are available in the final guidance.
The FDA considers the following when determining whether to qualify a proposed MDDT:
- MDDT description. Is the MDDT adequately described?
- Context of use. Is the proposed context of use adequately and appropriately defined?
- Public health impact. Would the scope and use of the tool have a broad public health impact?
- Strength of evidence. Does the available scientific evidence demonstrate that the MDDT reliably and accurately measures what is intended, is scientifically plausible, and is reasonably likely to predict the outcome of interest?
- Assessment of advantages and disadvantages. Within the specified context of use and given the available strength of evidence, do the advantages outweigh potential disadvantages of making decisions based on measurements obtained using the MDDT? Of particular importance are regulatory, public health, and/or clinical impact.
The FDA is excited to announce that we have qualified the first tool under the MDDT program.
The FDA will publicly list MDDTs in the table below once they are qualified, along with a summary of evidence and basis of qualification for the tool. This information 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, and information on how to contact the tool developer about accessing the tool.
|Name of Tool||Summary of Evidence and Basis for Qualification (SEBQ)||Product Area(s)||Tool Type||Date Qualified|
|Rubric for Applying CVSS to Medical Devices||Qualification Summary||Cybersecurity||NAM||10/20/2020|
|BREAST-Q Reconstruction Module||Qualification Summary||Plastic Surgery||COA||08/20/2020|
|Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) Questionnaires||Qualification Summary||Automated Insulin Dosing (AID)||COA||06/24/2020|
|IMAnalytics with MRIxViP1.5T/3.0T And BCLib||Qualification Summary||Active implanted medical devices (AIMDs)||NAM||12/12/2019|
|Tissue Mimicking Material (TMM) for Preclinical Acoustic Performance Characterization of High Intensity Therapeutic Ultrasound (HITU) Devices||TMM Qualification Summary||Imaging||NAM||07/10/2019|
|OSIRIX CDE Software Module||Qualification Summary||Neuro||BT||03/12/2019|
|Minnesota Living with Heart Failure Questionnaire (MLHFQ)||MLHFQ Qualification Summary||Cardio||COA||03/19/2018|
|Kansas City Cardiomyopathy Questionnaire (KCCQ)||KCCQ Qualification Summary||Cardio||COA||10/19/2017|
The FDA will not place limitations or requirements on MDDT licensing or fees, or the degree of access to intellectual property associated with an MDDT that a tool developer may give to a device sponsor. Prior to participating in the program, the tool submitter can discuss with the FDA during the proposal phase the level of information they deem appropriate for public disclosure.
The FDA only intends to qualify tools where the information contained in the summary of evaluation and basis for qualification can be made public.
More information about the qualification process is in the MDDT Program Federal Register Notice.
- Summary of Evidence and Basis of Qualification (SEBQ) Template
- Webinar - CDRH Final Guidance: Qualification of Medical Device Development Tools - August 24, 2017
- Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff