FDA's device RWE guidance (final, December 2025)
CDRH and CBER issued "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" on December 18, 2025 (docket FDA-2023-D-4395). It clarifies "how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE)," and it "supersedes the final guidance of the same name, issued August 31, 2017."
- Core test. Sponsors should demonstrate "whether the RWD are relevant and reliable for a particular regulatory decision," and the recommendations "apply regardless of the RWD source."
- History. A draft was issued December 19, 2023 to meet FDORA section 3629 (Consolidated Appropriations Act, 2023); the final meets a MDUFA V commitment. The notice also adds clarity on data from devices under EUA and on CLIA, such as Waiver by Application.
- Transition. FDA set "a 60-day transition period"; "beginning on February 17, 2026, the FDA generally anticipates that sponsors will be ready to include the newly recommended information," and will review such information "if submitted at any time."
Sources: FDA guidance page; guidance PDF; Federal Register, Dec 18, 2025 (90 FR 59127); FDA town hall page. This page is a summary, not regulatory advice.
When wearables are the data source
FDA's final guidance on digital health technologies for remote data acquisition (December 2023) covers DHT selection, verification and validation, endpoints, risk management and data protection. Fit-for-purpose means "the level of validation associated with the DHT is sufficient to support its use."
Source: FDA DHT guidance (final, Dec 2023).
Methods and reporting references
| Area | Reference | Citation |
|---|---|---|
| Study design | Target trial emulation | Hernán & Robins, Am J Epidemiol 2016 |
| Reporting, observational studies | STROBE | STROBE, von Elm et al. 2007 |
| Reporting, routinely collected data | RECORD (extends STROBE) | RECORD, Benchimol et al. 2015 |
| Good practices | Joint ISPOR-ISPE task force | Berger et al. 2017 (ISPOR-ISPE); Wang et al. 2017 |
What it means for startups
Our reading (editorial, not from a source):
- Source type is not enough. EHR, claims, registry or wearable data are each judged on relevance and reliability for the specific decision.
- Recheck older plans. Plans written against the 2017 guidance should be updated for what the 2025 guidance newly recommends.
- Design before data. Write the protocol as an emulated target trial and plan reporting with STROBE or RECORD.
- Talk to FDA early, for example through a Q-Submission, if your approach differs from the guidance.
Related resources
Frequently asked questions
What does FDA's 2025 device RWE guidance change?
It replaces the 2017 guidance and clarifies how FDA judges whether real-world data are relevant and reliable enough to generate real-world evidence for a device decision.
When did the new RWE recommendations take effect?
FDA set a 60-day transition; beginning February 17, 2026, it generally expects sponsors to include the newly recommended information.
Can wearable data be real-world evidence?
Wearable data can be a source of real-world data, judged on relevance and reliability like any other source, and the device collecting it needs fit-for-purpose validation.
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