CDRH and Real-World Evidence

CDRH Real-World Evidence Program

Today’s healthcare ecosystem generates rich and diverse data streams, providing new opportunities to modernize evidence generation for use by patients, providers, manufacturers, and regulators. The FDA’s Center for Devices and Radiological Health (CDRH) has long recognized the value of using Real-World Data (RWD) to inform regulatory decisions and is committed to advancing more efficient approaches to generating relevant and reliable Real-World Evidence (RWE) from RWD.

As defined by the FDA, RWD are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWE is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD. Examples of RWD sources, if they include data that are routinely collected, include electronic health records (EHRs), registries, administrative claims data, device-generated data, patient-generated data, public health surveillance data, clinically annotated biobanks, medical device data repositories, and chargemaster and/or billing data.

These data offer opportunities to generate evidence and understand clinical outcomes using routinely collected data outside of traditional clinical studies. In support of CDRH’s mission to protect and promote public health by ensuring the safety and effectiveness of medical devices, while assuring patients have timely access to them, CDRH aims to foster the use of RWE to support regulatory decision-making throughout the medical device total product lifecycle (TPLC). These efforts include facilitating collaboration across the FDA and with interested parties, maintaining knowledge management, ensuring transparency, and driving innovation. CDRH’s Office of Clinical Evidence and Analysis (OCEA) supports these efforts. Some of the key CDRH efforts that support appropriate use of RWD and RWE in regulatory decision making are listed below.

Featured Activities

Guidance

CDRH issued the FDA’s first guidance on RWD and RWE in 2017. The guidance provided clarity on how CDRH evaluates the relevance and reliability of RWD to support medical device regulatory decision-making. Subsequently, the FDA updated the guidance in 2025, which incorporated lessons learned through the FDA’s experience with RWD since the original guidance was released, and which fulfilled the Center’s commitments under both the Medical Device User Fee Amendments V of 2022 and the Food and the Drug Omnibus Reform Act of 2022. The 2025 RWE Guidance provides expanded and updated recommendations to FDA staff and to sponsors considering using RWE to support regulatory submissions for medical devices. Additionally, as part of CDRH’s implementation of the 2025 RWE Guidance, the Center has updated the electronic submission template and resource (eSTAR) forms to be consistent with recommendations in the guidance regarding submissions containing RWD and RWE.

RWE Examples

CDRH has curated a contemporary set of examples demonstrating the use of RWE in medical device regulatory decision-making. Building on the prior 90 Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions from fiscal years (FY) 2012-2019, CDRH conducted an additional review of public-facing decision summaries for devices authorized between FY 2020-2025. CDRH identified 73 additional premarket Examples of Real-World Evidence Used in Medical Device Regulatory Decisions (Fiscal Years 2020–2025) that highlight the continued evolution and increasing sophistication of RWE applications. While not exhaustive, these examples (FY 2012-2025) illustrate the various ways RWE can be used as valid scientific evidence to support regulatory decisions across the TPLC.

Training

CDRH has established internal RWE training to help ensure staff have the appropriate resources to evaluate RWD and RWE in medical device submissions. This training encompasses the growing use of RWD and RWE across submission and device types in both premarket and postmarket settings. Reviewers from all Offices within the Office of Product Evaluation and Quality (OPEQ) receive specialized training to ensure consistency in RWD and RWE assessment across the organization. The training covers issues including evaluating the relevance and reliability of RWD derived from a variety of sources, best practices for RWE review, and when to engage with subject matter experts. This approach supports the FDA's commitment to leverage the benefits of RWD and RWE, while maintaining rigorous standards for regulatory decision-making, ensuring that sponsors can rely on consistent and expert evaluation of their RWE submissions across all OPEQ review teams.

Device Identification

Reliable identification of the subject medical device is essential when using RWD to generate RWE for regulatory decision-making. Unique Device Identifiers (UDI) is a potentially rich and uniform way to detail medical devices in RWD to generate RWE. Innovative methodologies for medical device identification within RWD sources—such as utilizing automated data capture, supply chain records, and AI-driven natural language processing—are crucial for transforming unstructured RWD into actionable evidence, ultimately enabling precise, patient-level traceable use of medical devices in RWD for regulatory decision-making across the TPLC.

NEST

The FDA collaborated with interested parties in the medical device ecosystem to build the National Evaluation System for health Technology (NEST) to generate better clinical evidence, including RWE derived from RWD, and to do so efficiently for medical device evaluation and regulatory decision-making. The NEST Coordinating Center, in partnership with the FDA and interested parties, assesses and identifies high-quality RWD sources that can be used for premarket regulatory decisions. This comprehensive approach will enable more robust and efficient use of RWE to characterize the performance of medical devices in real-world settings.

Additional Resources

Contact Information

We encourage manufacturers to engage early with the FDA by submitting a Pre-Submission to discuss RWD use in their regulatory submission.

For more information on RWE, please contact CDRHClinicalEvidence@fda.hhs.gov.