FDA guidance on using Real-World Evidence (RWE) for medical device regulatory decisions

24th December 2025

FDA guidance on using Real-World Evidence (RWE) for medical device regulatory decisions

Summary: This FDA guidance explains how manufacturers and researchers can use Real-World Evidence (RWE)—derived from Real-World Data (RWD) such as electronic health records, registries, claims data and device-generated data—to support regulatory decisions for medical devices. It outlines when RWE may be appropriate for premarket submissions (including 510(k), De Novo, and PMA pathways) and post-market evaluations, and sets expectations for study design, data quality, relevance, reliability, and transparency. The guidance emphasises that RWE should be “fit for purpose”, with clear documentation on data provenance, methods to minimise bias and confounding, and robust statistical analysis plans. It also encourages early engagement with FDA to agree on approaches, particularly for innovative devices and where RWE may reduce the need for traditional clinical trials.

Link: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Back to Recent News