Update: October 17, 2023
The FDA’s Center for Devices and Radiological Health and the National Institutes of Health’s (NIH’s) National Cancer Institute are collaborating to support the small business community in developing innovative medical device development tools (MDDTs) through a new funding opportunity.
NIH/National Cancer Institute
The funding opportunity is available for small businesses through November 14, 2023.
The FDA's Medical Device Development Tools (MDDT) program is intended to facilitate device development, 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.
On this page:
- Why the FDA Developed the MDDT Qualification Process
- Qualified Medical Device Development Tools (MDDTs)
- MDDT Categories
- MDDT Qualification and the Qualification Process
- How to Participate in the MDDT Program
- CDRH Funding Opportunities: Small Business Innovation Research (SBIR) Grant Program
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.
Before 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 the 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 substantiated 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.
The FDA has qualified MDDTs for a wide range of device types such as cardiovascular, neurology, ophthalmology, plastic surgery, automated insulin dosing, and imaging devices, as well as crosscutting tools for 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 regulatory submission that relies on a qualified MDDT can include the MDDT submission number in the cover letter or the FDA CDRH Premarket Review Submission Cover Sheet form 3514 (Section F). The MDDT submission number for each qualified tool can be found in the SEBQ.
The FDA recognizes three categories of MDDTs, which can be distinguished primarily by how the tool measures the relevant parameters:
- Non-clinical Assessment Model (NAM) is a non-clinical test model or method that measures or predicts parameters of interest in regard to device safety, effectiveness, or device performance. For example:
- Human or animal-based models to replace clinical testing;
- in vitro models to replace animal testing;
- tissue and other material phantoms to evaluate imaging or other devices; and
- physics-, chemical-, or biological- based computational models.
- 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.
- Clinical Outcome Assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider, a patient, a non-clinical observer (such as a parent), or through performance of an activity or task. COAs could be collected in the clinic or remotely (e.g., collected with the use of digital health technologies). For details on COAs, see Clinical Outcome Assessments (COAs) in Medical Device Decision Making.
More information about the categories of MDDT is in the final guidance, Qualification of Medical Device Development Tools.
MDDT qualification is a conclusion that within the stated context of use, the results of an assessment that uses an MDDT can be relied upon in device evaluation and to support regulatory decision-making.
The qualification process consists of two phases: The Proposal Phase and the Qualification 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.
Those interested in seeking acceptance into the MDDT program should submit a complete proposal package.
During this phase, the FDA can provide feedback to submitters on their plan to collect evidence to support qualification of the tool.
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 Summary of Evidence and Basis of Qualification (SEBQ) 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.
|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.
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, and facilitating increased adoption and use of qualified tools.
Fees: There are no fees associated with submitting a tool for qualification.
Questions: Email questions to MDDT@fda.hhs.gov. You may also want to refer to this webinar about the qualification of MDDT tools:
CDRH Funding Opportunities to Support Small Businesses in Regulatory Science and Evidence Generation
CDRH has its own Small Business Innovation Research (SBIR) grant program. The SBIR programs encourage domestic small businesses to engage in research and development with the potential for product commercialization. These grants may be applicable to a broad variety of efforts such as development of Voluntary Consensus Standards, research methods, and Medical Device Development Tools. To determine applicability of these funding opportunities for your product, please see SBIR Omnibus/Parent Grant Solicitation Program Description and Research Topics Document in the SBIR/STTR Omnibus section.
The FDA defines small business as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.
Previous Funding Opportunities for Small Businesses Developing Medical Device Development Tools
In 2022, the FDA's Center for Devices and Radiological Health (CDRH) and the National Institutes of Health (NIH) collaborated to support the small business community in developing innovative MDDTs. Below are the funding announcements from the collaboration.
NIH/National Cancer Institute
Topic 454 – Software to Evaluate Artificial Intelligence/Machine Learning Medical Devices in Oncology Settings
NIH/National Institute of Dental Craniofacial Research
Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials
- RFA-DE-23-006: Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 - Clinical Trial Not Allowed) (nih.gov)
- RFA-DE-23-007: Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R42 Fast-Track - Clinical Trial Not Allowed) (nih.gov)
- RFA-DE-23-008: Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (Fast-Track - R44 - Clinical Trial Not Allowed) (nih.gov)
NIH/National Institute of Drug Abuse
Novel Drug (DDT) and Medical Device Development Tools (MDDT) for New Therapies for Substance Use Disorders (SUD)
- RFA-DA-23-019: Novel Drug (DDT) and Medical Device Development Tools (MDDT) to Help Expediate Creation and Regulatory Approvals of New Therapies for Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional) (nih.gov)
- RFA-DA-23-020: Novel Drug (DDT) and Medical Device Development Tools (MDDT) to Help Expedite Creation and Regulatory Approvals of New Therapies for Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional) (nih.gov)
If you have questions about the MDDT Program, email MDDT@fda.hhs.gov.