FDA to take a more relaxed approach to the use of Real-World Evidence (RWE) in Device (and potentially drug) Application Reviews.
Author:
Dr Susan McCune
Executive Principal Medical Consultant
Key Details
On December 15, 2025, the FDA published the final guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Dr. Makary said that the FDA is, “removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster.”
He added, “This common-sense reform will unlock access to vast databases like cancer and cystic fibrosis registries that contain critical insights about how treatments work in the real world.” (FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews | WebWire) The comments from Dr. Makary suggest that the Agency is considering a similar approach for drugs and biologics. Historically, the FDA has required that RWE elements include private, confidential information at the individual patient level. The new guidance allows meaningful information to be obtained from big data sources that do not contain individual-level personal information. The RWE data submitted to the FDA will be assessed based on the strength of the data based on an application-by-application review. This policy change allows the use of de-identified databases that house millions of patient records, including cancer registries, databases from hospital systems, insurance claims, and electronic health records. (FDA loosens restrictions on using patient-level RWD in medical device submissions | RAPS)
What this means for sponsors / how they can benefit:
The publication of the final guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” and the comments from Dr. Makary suggest that a similar approach to the use of RWE to support regulatory applications for drugs and biologics will be published soon. Historically, it has been difficult for sponsors to use data from sources that provide aggregate-level data because of the restriction for having individual patient level data. FDA will now review the RWE data on an application-by-application basis.
Eligibility or key requirements:
While Dr. Makary stated that the FDA is removing barriers to the inclusion of RWE in regulatory applications, each program will be considered separately, so it is important to have discussions with the FDA about how to use RWE in your specific program.
How Scendea can support:
Scendea has extensive experience incorporating RWE into the regulatory strategy for drug and biologic therapeutic programs. Scendea can work with you to schedule an early meeting with the FDA to discuss how to efficiently leverage the use of RWE data in your program.