Real-World Data Archives - Quality Solutions Now (QSN)

Inside FDA’s “TEMPO” Pilot
FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s [...]
FDA Finalizes Real-World Evidence Guidance for Medical Devices: What It Means (and How to Use It)
FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 [...]