FDA's advisory panel split 6-4 on Galleri's effectiveness in the first-ever MCED test PMA review. Here's why the vote diverged and what it means next.

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.

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.

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.

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.

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.

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.

What Regulation (EU) 2023/607 requires before the 2027 and 2028 MDR deadlines: legacy device conditions, EUDAMED, the 2025 simplification proposal and a close-out plan.

The Medical Device Single Audit Program promises one audit that satisfies multiple regulators. How MDSAP works in 2026, what changed with QMSR and the program's new governance, and how quality teams can prepare for an audit designed to find more than a standard ISO 13485 certification would.

How the EU AI Act applies to AI-enabled medical devices after the 2026 Digital Omnibus: high-risk classification, Articles 9–17, MDCG 2025-6 and an integration plan.

What FDA requires for cyber devices under Section 524B: the cyber device definition, SBOMs, threat models, testing, postmarket plans and the February 2026 guidance update.

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.

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

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.

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.

For thirty years, "checking MAUDE" has been shorthand for post-market vigilance in the medical device industry. It is the database regulatory teams cite in literature searches, the tool clinical affairs pulls up before a submission, the first stop for anyone trying to understand how a device is behaving once it leaves the controlled world of a clinical trial and enters the far messier world of actual patients. By the end of May 2026, it will not exist in its current form.

FDA just closed one of the more debated gray areas in device submissions — and industry has one week to get ready for the follow-up discussion. On May 29, FDA finalized its guidance on Human Factors information in device marketing submissions, replacing the 2022 draft.

Manual compliance monitoring is costing more than you think. Missed updates, delayed launches, audit findings, staff burnout—the hidden costs pile up. In this article, we explore how AI-powered regulatory intelligence uncovers risks early, saves millions in lost revenue, and frees regulatory teams to focus on strategy.

Choosing the right material for a medical device goes far beyond engineering performance—it determines regulatory risk, time-to-market, and patient safety. From unexpected leachables to shifting FDA expectations, biocompatibility challenges can derail even the most innovative designs. Explore how proactive strategies and expert consulting can turn material selection from a hidden risk into a competitive advantage.

Regulatory guidance is full of answers—if you can find them. See how Natural Language Processing makes it possible to instantly extract, map, and apply FDA and ISO requirements across your product development process. Learn how Lexim transforms static guidance into real-time regulatory intelligence.