FDA Issues Draft Guidance on Real-World Evidence Use

January 22, 2024

by Nathan Downing

In December 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices. While the guidance is currently in draft form (and subject to public comment), the FDA is likely to adopt final guidance in a substantially similar form—and, as a result, it is worth reading as medical device company executives plan for the future.


As the FDA states in its introduction to the draft guidance, its purpose is “to clarify how FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in FDA regulatory decision-making for medical devices.” The draft guidance defines real-world data (RWD) as, “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources,” while it defines real-world evidence (RWE) as, “clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” 

Factors for Assessing Whether RWD is Fit-for-Purpose

In its draft guidance, the FDA proposes a list of factors that it intends to consider when determining whether RWD are fit-for-purpose during its regulatory decision-making processes. In Section V of the draft guidance, the FDA explains that it will, “evaluate the same factors to assess RWD across all data sources and regulatory decisions but will weigh each factor in accordance with the regulatory decision to be made.” The factors outlined in the FDA’s draft guidance, which focus on relevance and reliability, include:


  • Data availability
  • Linkages between data sources
  • Timeliness
  • Generalizability of the data


  • Data accrual (manner of collection)
  • Data quality and integrity

Expanded Recommendations for Submitting RWE to the FDA

In addition to listing the factors that it intends to assess when making regulatory decisions regarding medical device submissions, the FDA’s draft guidance also provides expanded recommendations for companies that are considering using RWE in support of their regulatory submissions. For example, in Appendix A, the FDA outlines a set of proposed elements to be included in documentation submitted for review. Appendix A includes two separate tables focused on its proposed relevance and reliability factors, with each table breaking down the information that companies should document and have available for potential inspections, as well as where companies should include this information in their FDA submissions.

Appendix B similarly provides recommendations for the type of regulatory decisions the FDA makes that may be supported by RWE. While these examples are fairly fact-specific, they are nonetheless instructive as to how the FDA is proposing to consider RWE during its regulatory decision-making processes in the future.


While the FDA’s proposed guidance on RWD and RWE remains in draft form, it is nonetheless instructive for medical device manufacturers that are preparing for future submissions as it shares FDA’s current thinking on the subject. If you have questions about any aspect of the FDA submission process, the team at Gardner Law can help.

If you have any questions about privacy laws, contact the team at Gardner Law.