Medical Device Development Tools (MDDT) Qualification Program
This guidance outlines a voluntary program for qualification of medical device development tools (MDDTs) used in evaluating devices regulated by CDRH. It describes the framework for proposing and qualifying MDDTs, including definitions, evaluation criteria, qualification considerations, and qualification package contents. The guidance aims to facilitate medical device development through more efficient and predictable means of collecting regulatory information.
What You Need to Know? 👇
What is the difference between MDDT qualification and FDA device clearance/approval?
MDDT qualification evaluates tools for device development and regulatory assessment, focusing on performance characteristics and reliability. Device clearance/approval evaluates safety and effectiveness for patient treatment. Qualified MDDTs cannot be used for clinical diagnosis without proper FDA authorization.
How long does the MDDT qualification process typically take?
The proposal phase takes approximately 90 days for FDA review and decision notification. The qualification phase timeline varies depending on the complexity of the tool, context of use, and evidence required, but no specific timeframe is provided in the guidance.
Can multiple companies use the same qualified MDDT?
Yes, once qualified for a specific context of use, any medical device manufacturer can use the MDDT for that qualified purpose. FDA encourages tool developers to make qualified MDDTs publicly available, including under licensing arrangements, to streamline device development across the industry.
What are the three main categories of Medical Device Development Tools?
The three categories are: Non-clinical Assessment Models (NAMs) for predicting device parameters, Biomarker Tests (BTs) for detecting/measuring biomarkers, and Clinical Outcome Assessments (COAs) for measuring how patients feel, function, or survive during device evaluation.
Is MDDT qualification mandatory for medical device development?
No, MDDT qualification is entirely voluntary. Medical device manufacturers can choose whether to use qualified MDDTs or other scientifically valid tools and approaches. The existence of qualified MDDTs doesn’t create requirements for their use in development or evaluation.
What factors does FDA prioritize when reviewing MDDT proposals?
FDA prioritizes tools addressing life-threatening conditions, underserved populations, novel technologies without established assessment paradigms, areas with no alternatives or unmet scientific needs, tools offering safer/less invasive measurements, and those potentially impacting multiple device development programs.
What You Need to Do 👇
Recommended Actions
- Determine if your tool meets MDDT definition and categories (NAM, BT, or COA)
- Prepare and submit Proposal Package including:
- MDDT Description
- Context of Use
- Performance criteria
- Qualification Plan
- Assessment of advantages/limitations
- If proposal accepted, prepare Qualification Package with:
- Complete tool evidence
- Performance characteristics data
- Reliability and reproducibility evidence
- Updated advantages/limitations assessment
- Ensure clear labeling distinguishing MDDT qualification from FDA clearance/approval
- Plan for public disclosure through SEBQ if qualified
- Consider forming consortia or collaborations to expedite tool development
- Maintain ongoing communication with FDA throughout the qualification process
- Document any limitations or constraints on tool applicability
- Prepare licensing/access strategy if tool becomes qualified
- Monitor for potential changes that may affect qualification status
Key Considerations
Clinical testing
- MDDTs can be used for patient selection and study population enrichment
- Can be used for intermediate endpoint measurements
- Can support remote monitoring and endpoint collection
- Can be used for post-market surveillance methodologies
Non-clinical testing
- Can reduce test duration or minimize sample size
- Can replace standardized non-clinical bench performance tests
- Can replace human studies with animal or engineering models
- Can reduce or minimize animal use through simulation or tissue scaffolds
Labelling
- Tool developers should clearly indicate that MDDT qualification does not constitute FDA clearance/approval
- Should separate FDA-regulated labeling from MDDT materials for products that are also legally marketed medical devices
- Should prominently convey qualified Context of Use limitations
Safety
- Can be used to determine technical parameters for labeling to ensure patient safety
- Can be used for toxicology assessments
- Should identify safety limitations within the Context of Use
Other considerations
- Performance criteria must be objectively defined with acceptance criteria
- Evidence must demonstrate tool provides accurate and precise measurements
- Tool reliability and reproducibility must be demonstrated
- Advantages and limitations must be clearly assessed
- Public disclosure of qualified tools through Summary of Evidence and Basis of Qualification (SEBQ)
Relevant Guidances 🔗
- Design Controls for Medical Device Manufacturers
- Least Burdensome Principles for Medical Device Regulation
- Benefit-Risk Determinations for Medical Device Premarket Review
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms 📂
- BEST (Biomarkers, EndpointS, and other Tools) Resource