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Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions

This guidance clarifies FDA's evaluation process for real-world data (RWD) to determine if it can generate real-world evidence (RWE) suitable for regulatory decision-making for medical devices. It applies to all devices, including software that meets the device definition. The guidance focuses on the characteristics and quality requirements of RWD sources to support various regulatory decisions.

  1. Evaluate RWD sources for relevance and reliability before use in regulatory submissions
  2. Develop standardized data collection procedures and quality control processes
  3. Create detailed study protocols and analysis plans before accessing RWD
  4. Implement appropriate data monitoring and quality assurance programs
  5. Ensure adequate documentation of data collection and quality control procedures
  6. Consider using the FDA pre-submission process when planning to use RWE
  7. Verify that patient protection and privacy requirements are met
  8. Maintain records of quality assurance and control activities
  9. Ensure proper device identification within RWD sources
  10. Validate data consistency and completeness across collection sites

Key Considerations

Clinical testing

  • RWD can be used to generate evidence for safety and effectiveness determinations
  • Study protocols and analysis plans must be created prior to accessing RWD
  • Clinical evidence from RWD must meet valid scientific evidence standards
  • IDE requirements may apply when RWD collection influences treatment decisions

Labelling

  • RWE can support labeling changes and expanded indications for use
  • RWD must adequately capture device identification information

Safety

  • RWD must be sufficient to capture safety outcomes
  • Quality control and data assurance processes must be in place
  • Data elements must be complete and consistent across sites

Other considerations

  • 21 CFR 812: Investigational Device Exemptions
  • 21 CFR 56: Institutional Review Boards
  • 21 CFR 50: Protection of Human Subjects
  • 21 CFR 54: Financial Disclosure by Clinical Investigators

Original guidance

  • Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
  • HTML / PDF
  • Issue date: 2017-08-31
  • Last changed date: 2023-06-26
  • Status: FINAL
  • Official FDA topics: Ophthalmic, Real World Data / Real World Evidence (RWD/RWE), Adverse Event Reporting System (FAERS), Physical Medicine, Medical Devices, Obstetrical & Gynecological, Cardiovascular, Postmarket, Adverse Event Reporting, Anesthesiology, Biostatistics, Antimicrobial Resistance, Immunology & Microbiology, Orthopedic, Molecular and Clinical Genetics, Neurological
  • ReguVirta summary file ID: eca8fe7dc0bfb11741224ba70c33dbbc
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