3.3 Formal qualification programs
Exploring MDDT and DDT pathways
Qualification programs offer a pathway to formally establish that a digital measure or sDHT is fit-for-purpose for a specific context of use or intended use, enabling reuse across multiple development programs without re-review.
Overview
Formal qualification is a voluntary process that results in FDA’s endorsement of a measure or tool for a specific context of use. Once qualified, the tool can be used by any sponsor for that qualified purpose without FDA needing to re-review its suitability. The [MDDT] (Medical Device Development Tool) and [DDT] (Drug Development Tool) qualification programs operate as an overlay on top of (not substituting for) the existing drug and device regulatory pathways, rather than as standalone approval pathways. Additionally, some, but not all, sDHTs may fall under the ISTAND program (which is part of the DDT program).
Evaluate drug, device, or combination product pathways for the medical product itself, and consider tool-specific qualification pathways when your sDHT is intended for reuse across programs within a defined context of use.
Qualification is not required for most sDHT applications
If you’re using an sDHT-derived endpoint in a single development program, you can establish its fitness through your product-specific regulatory interactions. Qualification is a valuable option when:
The measure addresses a broadly applicable need across multiple sponsors or therapeutic programs
You want to reduce duplicative evidence generation across the field
You’re building a tool intended for widespread adoption and want formal regulatory endorsement to support that goal
Two primary qualification pathways exist
MDDT (Medical Device Development Tool)
Administered by: CDRH
For use in: Medical device development programs
Outcome: CDRH reviewers accept the qualified MDDT for its stated context of use or intended use without re-confirming suitability
DDT (Drug Development Tool)
Administered by: CDER/CBER
For use in: Drug and biologic development programs
Outcome: The qualified DDT can be relied upon for its stated context of use in IND, NDA, or BLA submissions without re-review
Before pursuing qualification, ask:
Is the measure intended for use beyond a single development program?
Is there unmet need in the field that qualification would address?
Do you have (or can you generate) sufficient evidence to meet the evidentiary bar?
Are you prepared for a multi-year process?
If the answer to any of these is “no,” product-specific engagement (covered in Section 3.2: Pathway selection & timing) may be more appropriate.
in practice
3.3A MDDT Qualification Program
The Medical Device Development Tool (MDDT) Qualification Program provides a pathway for FDA to formally qualify tools, including sDHTs, that medical device sponsors can use in device development and evaluation.
What qualifies as an MDDT?
MDDTs include biomarker tests, clinical outcome assessments (including patient-reported, clinician-reported, observer-reported, and performance outcomes), non-clinical assessment models, and digital health technologies like sensors or wearables.
What does qualification mean?
“Qualification is a conclusion based upon FDA review of the MDDT Qualification Package. A qualification decision signifies that the MDDT can be relied upon to facilitate regulatory decision making when it is used according to the qualified [context of use (COU)] or [intended use].”
– Section II (Definition of Key Concepts), p. 2, Qualification of Medical Device Development Tools, July 17, 2023 (FDA)
Once qualified, CDRH reviewers can accept the MDDT for its qualified context of use or intended use without needing to reconfirm its suitability. This reduces burden for both sponsors and FDA when the same tool is used across multiple device submissions.
When to consider MDDT qualification
MDDT qualification is best suited for:
✓ sDHTs addressing measurement gaps that affect multiple device development programs (e.g., a validated digital measure for a symptom or function not well-captured by existing tools)
✓ Developers seeking to establish broad utility for their technology across the medical device ecosystem
✓ Consortia or collaborative initiatives pooling resources to qualify a shared tool
MDDT qualification is likely not the right path if:
✘ You need the sDHT for a single device trial (use Q-Sub process instead)
✘ Your validation evidence is still early-stage
✘ You lack resources for a multi-stage, multi-year process
The MDDT Qualification process
The process involves three main stages:
| Purpose | Discuss your proposed MDDT, context of use or intended use, and planned evidence with FDA |
| Outcome | Feedback on whether MDDT pathway is appropriate; guidance on evidentiary expectations |
| Purpose | Submit complete evidence package demonstrating the MDDT is fit-for-purpose for the stated context of use or intended use |
| Outcome | FDA review and evaluation |
| Purpose | FDA determines whether the MDDT meets qualification standards |
| Outcome | If qualified: public listing and acceptance for stated use. If not: feedback on gaps |
Key elements of a qualification package:
- Clear statement of context of use or intended use (population, setting, purpose)
- Comprehensive validation evidence (verification, analytical validation, clinical validation, usability)
- Demonstration that the tool reliably measures what it claims to measure
- Evidence that results are meaningful and interpretable for the stated use
in practice
3.3B DDT Qualification Program
The Drug Development Tool (DDT) Qualification Program provides pathways for FDA to formally qualify tools—including sDHT-derived measures—that drug and biologic sponsors can rely upon in their development programs.
What qualifies as a DDT?
DDTs include biomarkers, clinical outcome assessments (COAs), and animal models. For sDHTs, the relevant pathways are typically:
Clinical Outcome Assessment (COA) Qualification: For sDHT-derived measures that capture how a patient feels, functions, or survives
Biomarker Qualification: For sDHT-derived measures that indicate a biological process, disease state, or response to treatment
What does qualification mean?
“Qualification is a conclusion that within the stated context of use, the DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review. Once qualified, DDTs will be publicly available to be used in any drug development program for the qualified context of use. Additionally, the qualified DDT generally can be included in IND, NDA, or BLA submissions without needing FDA to reconsider and reconfirm its suitability.”
– Drug Development Tool (DDT) Qualification Programs, FDA, 2025
When to consider DDT qualification
DDT qualification may be appropriate when:
✓ Measures addressing cross-program needs where multiple sponsors would benefit from a shared, qualified tool
✓ Endpoints for conditions with limited existing measures where an sDHT-derived measure fills a gap
✓ Precompetitive initiatives where consortia, patient groups, and industry collaborate to qualify a measure for broad use
DDT qualification is likely not the right path if:
✘ You need the measure for a single drug program (use PDUFA meetings instead)
✘ You lack resources for a multi-stage, multi-year qualification process
The DDT Qualification process
The process involves three main stages:
| Purpose | Notify FDA of your intent to pursue qualification; describe the proposed DDT and context of use |
| What you submit | Summary of the tool, proposed use, and preliminary rationale |
| Outcome | FDA acknowledgment; initial feedback on appropriateness |
| Purpose | Present your evidence generation strategy |
| What you submit | Detailed plan for validation studies; existing evidence summary |
| Outcome | FDA feedback on whether the plan, if executed, could support qualification |
| Purpose | Submit complete evidence demonstrating fitness for stated context of use |
| What you submit | Comprehensive validation data; clinical meaningfulness evidence; complete documentation |
| Outcome | FDA qualification decision |
Timeline: The full process typically spans several years. FDA provides feedback at each stage, but qualification is not guaranteed; evidence must meet a high bar.
COA vs. Biomarker: Which Pathway?
For sDHT-derived measures in drug development, the classification of your measure affects the evidentiary expectations and qualification pathway:
| If your measure… | It’s likely a… | Qualification pathway | Key evidentiary focus |
|---|---|---|---|
| Captures how a patient feels, functions, or survives | Clinical Outcome Assessment (COA) | For the Clinical Outcome Assessment (COA) Qualification Program, FDA offers a COA Qualification Program orientation session and slide deck. You can submit inquiries to COADDTQualification@fda.hhs.gov. | Patient input; content validity; meaningful change threshold; psychometric properties |
| Indicates a biological process, disease state, or response to intervention | Biomarker | If you’re interested in the Biomarker Qualification pathway, FDA offers submission resources and accepts inquiries at CDER-BiomarkerQualificationProgram@fda.hhs.gov. | Analytical validation; clinical validation linking to disease/outcome; biological rationale |
Note: This classification should be established early (see Section 2.2: Context of Use) and confirmed through regulatory engagement before committing to a qualification pathway. Misclassification can result in pursuing the wrong evidentiary strategy.
What it takes to qualify a digital endpoint
In 2023, the European Medicines Agency (EMA) qualified stride velocity 95th centile (SV95C)—a measure derived from wearable sensors—as an acceptable secondary endpoint in Duchenne muscular dystrophy trials.
While this example comes from EMA rather than FDA, it illustrates the type of multi-stakeholder effort and evidentiary package that can support qualification of an sDHT-derived measure.
Key elements of the qualification:
Addressed a clear unmet need: existing endpoints (like the 6-minute walk test) were inadequate for the patient population
Built on years of collaborative work across industry, academia, and patient groups
Demonstrated that the measure captures meaningful aspects of patient function in daily life
Provided robust validation evidence across multiple studies
A note on global programs
This Roadmap focuses on FDA pathways, but many adopters and developers operate globally. The European Medicines Agency (EMA) offers parallel mechanisms for qualifying digital health technologies, including the Qualification of Novel Methodologies pathway that produced the SV95C qualification in Duchenne muscular dystrophy.
Evidence generated for FDA submissions can often support EMA applications (and vice versa), but terminology, procedural timelines, and evidentiary expectations differ between jurisdictions. Teams planning global programs should engage both agencies early and align context of use or intended use definitions across submissions.
For EMA-specific guidance, see:
To understand and compare regulatory environments across Asia Pacific, Europe, and North America and find country-specific guides, step-by-step flowcharts, and supporting resources, please visit DiMe’s International Digital Health Regulatory Pathways.
key takeaways
Regardless of whether you’re working in a medical device or drug/biologic context, several principles apply:
1. Qualification is optional and resource-intensive, but can yield significant value for future use.
It may be the right path when you’re building a tool for broad, multi-program use, not single-program applications.
2. Know which pathway applies.
MDDT qualification supports medical device submissions (CDRH). DDT qualification supports drug and biologic submissions (CDER/CBER).
3. Classification matters.
For DDT qualification, determine early whether your measure is a COA or biomarker, as this shapes your evidentiary strategy and the specific program you’ll pursue.
4. Engage FDA early in the qualification journey.
Use Pre-Submissions (for MDDT) or the Letter of Intent stage (for DDT) to confirm your approach.
5. Consider precompetitive collaboration.
Qualification is often more feasible when costs and evidence generation are shared across adopters, developers, patient groups, and academic partners.
3.3 Formal qualification programs
Resources to guide you
The sDHT roadmap library gathers 200+ external resources to support the adoption of sensor-based digital health technologies. To help you apply the concepts in this section, we’ve curated specific spotlights that provide direct access to critical guidance and real-world examples, helping you move from strategy to implementation.
Features essential guidance, publications, and communications from regulatory bodies relevant to this section. Use these resources to inform your regulatory strategy and ensure compliance.
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.