The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In a recent press announcement, the agency stated it has eliminated a long-standing requirement that often prevented certain datasets from being used in marketing submissions for regulated products.
The update has implications for drug and medical device applications, particularly those supported by large real world datasets that cannot be shared with identifiable patient-level information.
According to the FDA, the revised approach is intended to remove unnecessary barriers while preserving expectations around data quality, relevance, and reliability. The agency outlined this policy shift in its official announcement explaining how it will expand the acceptable use of real world evidence in application reviews.
What The FDA Changed In Its Review Approach
In its announcement, the FDA explained that it has removed a requirement that previously limited the use of real world evidence in certain submissions. Historically, the agency often expected identifiable individual patient data to be included when real world evidence was used to support regulatory decisions.
The FDA now states that, for certain medical device submissions, real world evidence may be considered even when identifiable patient-level data is not included in the marketing submission. The agency emphasized that this change does not lower evidentiary standards, but rather reflects a more flexible approach to how data is submitted and reviewed. Full details are provided in the FDA press announcement describing how the agency is eliminating a major barrier to using real world evidence in drug and device application reviews.
Why Real World Evidence Has Been Difficult To Use
Real world evidence is often derived from sources such as disease registries, electronic health records, claims databases, and other large datasets. These sources are frequently designed to protect patient privacy and, as a result, may not allow the sharing of identifiable individual records.
Because of this, many companies found that otherwise relevant data could not be used in regulatory submissions. The FDA acknowledged that this expectation limited the practical use of real world evidence, even when the data could address important questions related to safety, effectiveness, or performance.
The agency also noted that, since 2016, real world evidence has appeared in a relatively small number of drug, biologic, and vaccine applications compared to its use in medical device submissions. This imbalance contributed to the FDA’s decision to reassess how real world evidence is evaluated.
How This Update Affects Drug And Medical Device Applications
This policy change may expand the range of evidence that companies can consider when preparing submissions. While real world evidence is not a replacement for clinical studies, it can play a complementary role when it is fit for purpose and scientifically sound.
For drug and medical device applications, the update may be particularly relevant in situations where traditional clinical data is limited or where real world use provides additional insight into product performance. However, the FDA made clear that acceptance of real world evidence remains case-specific and depends on the quality, relevance, and context of the data.
Also, companies should note that the announcement specifically references certain medical device submissions, with the FDA indicating that it intends to consider similar updates for drugs and biologics in the future.
What to Consider for Compliance Planning
Although the update removes a major barrier, it does not eliminate the need for careful planning. Real world evidence still requires a clear regulatory rationale and thorough documentation. When preparing submissions, you may want to consider the following:
- Whether real world evidence directly addresses a defined regulatory question
- How data sources are governed, curated, and protected
- Whether analyses are transparent, reproducible, and aligned with the overall evidence package
Early alignment between regulatory strategy, data selection, and submission planning remains critical to avoiding delays or deficiencies during review.
Frequently Asked Questions
Does this mean real world evidence is now sufficient on its own?
No. The FDA did not state that real world evidence can replace clinical data. It may be used to support specific questions when it is appropriate and scientifically robust.
Does the change apply to all submission types?
Not at this time. The FDA described the update in the context of certain medical device submissions and noted that additional guidance for drugs and biologics may follow.
Is patient privacy still a concern for FDA submissions?
Yes. The update is designed to allow the use of privacy-protected datasets, not to remove privacy safeguards. Data quality and integrity remain essential.
Can this change improve submission efficiency?
Potentially. By reducing data access barriers, real world evidence may be incorporated more effectively into regulatory strategies for qualifying submissions.
Key Takeaways
- The FDA has removed a long-standing requirement that limited the use of real world evidence in certain submissions
- Identifiable patient-level data may no longer be required for specific medical device applications
- The agency intends to consider similar updates for drugs and biologics
- Real world evidence must still meet standards for relevance, reliability, and scientific rigor
- Regulatory strategy remains essential when integrating real world data into submissions
Conclusion
The FDA’s announcement marks a notable shift in how real world evidence may be used in regulatory reviews. For companies preparing or planning drug and medical device applications, this update may expand evidence options while maintaining regulatory expectations.
If you are evaluating how real world evidence fits into your submission strategy or need support aligning data, documentation, and regulatory pathways, Quality Smart Solutions can help. You can contact us to discuss how our regulatory experts support FDA compliance for drugs and medical devices across the full product lifecycle.
