News & Updates

Stay informed on the latest FDA developments from September 2026. This
comprehensive digest covers breakthrough oncology approvals based on ctDNA
biomarkers, important MoCRA compliance clarifications for cosmetic sellers,
updated AI and digital health device listings, and critical drug and
medical device safety recalls.

Stay compliant with key FDA medical device updates, including critical Class I recalls from Boston Scientific and Medline, plus new FDA AI guidance.

**Article Excerpt: Demystifying the FDA’s New Human Factors Guidance**

On May 29, 2026, the FDA issued a finalized guidance document. It introduces a brand-new, risk-based framework for medical device marketing submissions. Furthermore, this critical update requires manufacturers to classify their devices into one of three specific Human Factors (HF) Submission Categories. This classification relies heavily on a Use-Related Risk Analysis (URRA) and the presence of critical tasks. Read the full article to learn how to seamlessly navigate these new regulatory requirements, accurately determine your device’s category, and streamline your path to market.

Exploring insights from an FDA audit pause during PMA submission process.

CQG stands out among Qualio’s top medical device consultants for 2024.

Part 2 focuses on three ways manufacturers can leverage audits for streamlined entry, avoiding costly mistakes, and taking advantage of this underused tool to ensure U.S. Food and Drug Administration (FDA) compliance.

Discover the pivotal role of Laboratory Developed Tests (LDTs) in healthcare, their increasing importance, and changes to regulatory oversight.