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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
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
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
FDA Wants to Evaluate AI Devices the Way It Evaluates Doctors
FDA's Digital Health Center of Excellence has published a discussion paper on regulating generative AI-enabled medical devices, posing 26 detailed questions with a public comment docket open through October 19. What it signals about where FDA's thinking is headed, and how sponsors should respond.
Aug 195 min read
The Deal That Sets Device Review Speed Through 2032 Just Got Made
On August 5, FDA held a public meeting to walk through its proposed recommendations for reauthorizing the Medical Device User Fee Amendments — MDUFA VI — the negotiated agreement that will determine how FDA's device review program is funded and how fast it moves for fiscal years 2028 through 2032. That meeting matters because of what preceded it: FDA and industry, represented by AdvaMed and the Medical Device Manufacturers Association, had already reached an agreement in prin
Aug 106 min read
FDA Just Retired the Inspection Technique It Used for Nearly 30 Years
FDA retired QSIT, its 30-year device inspection framework, on Feb 2, 2026. Here's what the new QMSR-aligned, risk-based process means for your audits.
Aug 38 min read
The Human Factors Compliance Clock Just Ran Out
FDA's final Human Factors guidance takes effect this week. Here's what changed in the eSTAR template and what to check in your submission pipeline now.
Jul 273 min read
FDA's #1 QMSR Form 483 Audit Findings, In Its Own Words: "Risk, Risk, Risk, Risk"
Five months into FDA's new Quality Management System Regulation, the agency has said out loud what's actually showing up in QMSR Form 483 findings — and it's not a paperwork problem.
Jul 153 min read
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