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

What You Need to Know? 👇

What is Real-World Evidence and how does it differ from traditional clinical trial data?

Real-World Evidence (RWE) is clinical evidence derived from analysis of Real-World Data (RWD) - data collected during routine healthcare delivery from sources like EHRs, registries, and claims databases. Unlike controlled clinical trials, RWE reflects broader patient populations and real-world usage patterns.

When is an Investigational Device Exemption (IDE) required for collecting Real-World Data?

An IDE is typically not required when collecting RWD during normal medical practice with legally marketed devices. However, an IDE may be needed if data collection influences treatment decisions or involves prescribed administration for research purposes rather than routine patient care.

What are the key criteria FDA uses to evaluate Real-World Data quality for regulatory decisions?

FDA evaluates RWD based on two primary factors: relevance (whether data adequately address the regulatory question) and reliability (data collection methods and quality assurance processes). The assessment considers data completeness, accuracy, representativeness, and appropriate analytical methods.

Can Real-World Evidence support premarket approval or clearance of new medical devices?

Yes, under appropriate conditions, RWE may support device clearance or approval, particularly when traditional clinical trials are impractical. RWE can serve as historical controls, supplement clinical data, or provide evidence for expanded indications, depending on data quality and regulatory context.

How can medical device registries be used to meet FDA postmarket surveillance requirements?

Well-designed registries collecting high-quality RWD can fulfill Section 522 postmarket surveillance orders or post-approval study requirements. Multiple manufacturers can collaborate through professional societies to create shared registries that provide comparative data while reducing individual study burdens.

What role does the National Evaluation System for health Technology (NEST) play in medical device regulation?

NEST leverages RWD to identify safety problems more quickly and better understand device benefit-risk profiles. It aims to reduce time and costs for generating regulatory evidence while supporting both premarket submissions and postmarket surveillance requirements through coordinated data networks.

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What You Need to Do 👇

Recommended Actions

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

• RWD sources must be relevant and reliable for the regulatory purpose
• Data collection procedures must be standardized and documented
• Data quality assurance and monitoring plans must be implemented
• Patient protections and privacy requirements must be met
• Data linkage across sources must be scientifically appropriate
• Sufficient follow-up information must be available

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Relevant Guidances 🔗

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

Related references and norms 📂

• 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

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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 ID: eca8fe7dc0bfb11741224ba70c33dbbc