FDA Submissions Archives - Quality Solutions Now (QSN)

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 [...]
FDA Pauses Submissions Amid Government Shutdown: What You Can Do Now
The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and [...]