Zhaohui Su, VP of Biostatistics at Ontada, shared a post on LinkedIn:
“On December 18, 2025, FDA issued updated guidance on how real‑world data (RWD) can be used to generate real‑world evidence (RWE) to support regulatory decisions for medical devices.
The guidance expands the 2017 recommendations and applies across RWD sources, including EHRs, claims, registries, device‑generated data, and patient‑generated data. It emphasizes that RWD may be used for hypothesis generation, control groups, and pre‑ and post‑market evidence.
The guidance introduces a structured relevance and reliability assessment covering data availability, linkages, timeliness, generalizability, accrual, quality, and integrity.
FDA also highlights study‑design issues such as bias mitigation, choice of controls, and error control, while not mandating RWE use or specific designs. Sponsors are encouraged to flag RWE in submissions and provide protocols and justification of relevance and reliability.”
Read the full press release.
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