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Regulatory Intelligence,
In Depth.
Articles, whitepapers, guides, and case studies for Life Sciences regulatory professionals navigating a faster, more complex regulatory world.
Combination Product Jurisdiction: How FDA Decides Who Reviews Your Product
How FDA assigns drug-device, biologic-device, and drug-biologic combination products to CDER, CBER, or CDRH: primary mode of action, the Request for Designation process, and how sponsors should plan around jurisdiction early.
Sep 224 min read
Supplier and Outsourcing Controls Under QMSR: The Audit Records Exemption Is Gone
QMSR removed the exemption that long kept supplier audit records out of FDA investigators' reach. What that means for supplier and outsourcing controls under ISO 13485, and how to get supplier audit files inspection-ready.
Sep 224 min read
International Recognition and Reliance Pathways: The UK’s New Model for Device Access
The UK's draft International Reliance pathway would let device manufacturers build on approvals from trusted regulators such as FDA, TGA, and Health Canada to reach the Great Britain market faster. What's proposed, what's confirmed, and how to plan multi-market strategy.
Sep 224 min read
QMSR vs. QSR: What Actually Changed and What FDA Is Finding Five Months In
QMSR replaced the QSR on February 2, 2026, incorporating ISO 13485:2016 by reference. What actually changed for device manufacturers, what stayed the same, and what FDA investigators are finding in the first months of inspections.
Sep 224 min read
Breakthrough Device Designation in 2026: What the Data Actually Shows
Breakthrough Device Designation by the numbers: how many designations FDA has granted, how few have reached marketing authorization, and what the program actually changes for sponsors beyond the headline.
Sep 224 min read
Separating CAPA Workflows Under QMSR: What Manufacturers Actually Need to Change
CAPA deficiencies remain one of FDA's most reliable predictors of enforcement. What separating corrective and preventive action workflows looks like under QMSR, and what manufacturers actually need to change in their quality systems.
Sep 224 min read
Predetermined Change Control Plans: How PCCPs Are Reshaping AI/ML Device Submissions
How Predetermined Change Control Plans let AI/ML-enabled device makers pre-authorize specific model updates without a new marketing submission, what FDA expects a PCCP to contain, and how PCCPs are reshaping AI device regulatory strategy.
Sep 224 min read
Real-World Evidence in FDA Device Submissions: What Changed in 2026
FDA's December 2025 final guidance on real-world evidence for medical devices removed a major barrier to using real-world data in submissions. What changed in 2026, and what device sponsors need to do differently to put RWE to work.
Sep 224 min read
MDUFA VI Reauthorization: What It Means for Device Sponsors Through 2032
MDUFA VI will reset review timelines, staffing, and user fees for every device company working with FDA from fiscal 2028 through 2032. What the draft commitment letter changes, and what device sponsors should do now.
Sep 224 min read
510(k) vs. De Novo vs. PMA: Choosing the Right FDA Pathway
Every medical device company reaches the same fork in the road: which FDA pathway fits the device in front of them. Choosing wrong doesn’t just cost time — it can mean building an entire evidence package for the wrong evidentiary standard, then rebuilding it under regulatory pressure. This article walks through how the three primary pathways — 510(k), De Novo, and PMA — actually differ in practice, and how sponsors should be thinking about the decision in 2026. The Core Disti
Sep 224 min read
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