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Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making (DRAFT)

This guidance clarifies FDA's evaluation process for real-world data (RWD) to determine if it can generate real-world evidence (RWE) suitable for medical device regulatory decision-making. It applies to regulatory submissions for medical devices and provides expanded recommendations for sponsors considering using RWE to support submissions.

This is a draft guidance. Not for implementation.

  1. Conduct fit-for-purpose assessment of RWD relevance and reliability
  2. Document and provide in FDA submission:
    • Purpose of using RWE
    • Description of RWD sources
    • Study protocol and analysis plan
    • Data management and quality control plans
    • Human subject protections
    • Validation/adjudication results if conducted
  3. Ensure adequate documentation of:
    • Data collection procedures
    • Quality control processes
    • Data linkage methodologies
    • Changes in clinical practice
    • Missing data assessment
  4. Prepare regulatory submission including:
    • Cover letter identifying RWD/RWE components
    • Fit-for-purpose assessment
    • Protocol
    • Study report
    • Additional required documentation
  5. Consider early engagement with FDA through Q-submission program to discuss RWE approach

Key Considerations

Clinical testing

  • Clinical evidence can be generated from RWD alone or combined with traditional clinical studies
  • Studies using RWD should be carefully designed to mitigate potential bias
  • Protocol and analysis plan should be created prior to analyzing RWD
  • Sample size should be adequate to detect clinically meaningful differences

Safety

  • Safety assessment should be based on comparison of serious device-related adverse event rates
  • Adverse event reporting plans must be included
  • Safety endpoints and outcomes should be clearly defined

Other considerations

  • ICD-10-CM: International Classification of Diseases, Tenth Revision, Clinical Modification
  • LOINC: Logical Observation Identifiers, Names, and Codes
  • SNOMED CT: Systematized Nomenclature of Medicine Clinical Terms
  • CPT: Current Procedural Terminology

Original guidance

  • Use of Real-World Data and Real-World Evidence to Support Medical Device Regulatory Decision-Making
  • HTML / PDF
  • Issue date: 2023-12-14
  • Last changed date: 2024-02-07
  • Status: DRAFT
  • Official FDA topics: Radiation-Emitting Products, Real World Data / Real World Evidence (RWD/RWE), Medical Devices, Postmarket, Premarket
  • ReguVirta summary file ID: e27dd4ae6000d19be8c0d4480b326bc9
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