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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.

  1. Determine if your tool meets MDDT definition and categories (NAM, BT, or COA)
  2. Prepare and submit Proposal Package including:
    • MDDT Description
    • Context of Use
    • Performance criteria
    • Qualification Plan
    • Assessment of advantages/limitations
  3. If proposal accepted, prepare Qualification Package with:
    • Complete tool evidence
    • Performance characteristics data
    • Reliability and reproducibility evidence
    • Updated advantages/limitations assessment
  4. Ensure clear labeling distinguishing MDDT qualification from FDA clearance/approval
  5. Plan for public disclosure through SEBQ if qualified
  6. Consider forming consortia or collaborations to expedite tool development
  7. Maintain ongoing communication with FDA throughout the qualification process
  8. Document any limitations or constraints on tool applicability
  9. Prepare licensing/access strategy if tool becomes qualified
  10. 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

  • BEST (Biomarkers, EndpointS, and other Tools) Resource

Original guidance

  • Medical Device Development Tools (MDDT) Qualification Program
  • HTML / PDF
  • Issue date: 2023-07-17
  • Last changed date: 2023-07-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Digital Health, Administrative / Procedural, Premarket
  • ReguVirta summary file ID: ed49402028794c23a7b2b5eafc35bc6a
This post is licensed under CC BY 4.0 by the author.