In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]

The FDA’s CDRH has launched a pilot program to accelerate public communication of high-risk medical device recalls. Learn what this means for manufacturers and how to prepare your recall and risk management systems. […]

Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and [...]

Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to [...]

The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because [...]

Leading the Way in Life Sciences Compliance and Quality Management Quality Solutions Now (QSN) and ComplyFDA have joined forces to offer unparalleled solutions in quality management and regulatory compliance for the life sciences industry. This [...]