FDA Updates Recognized Standards Database — Plus MLV 2025 Year in Review

MedTech Leading Voice | Issue 144

This week’s update to the FDA’s recognized standards database brings new and revised requirements that will shape design decisions and documentation in 2026.

📝 From the Editor

The FDA’s December update added more than 100 newly recognized or revised consensus standards, including several that matter for teams working on medical electrical equipment, software-driven devices, and machine-learning systems. According to a new article by Leo Eisner, standards strategy is becoming a more visible part of design decisions, and Leo Eisner’s breakdown this week gives a clear view of what changed and where to focus.

Plus, a look back at some of the biggest MLV milestones of 2025.

— Sean Smith, Founder & Publisher

🎯 Featured Post

FDA Recognized Standards Update: What Changed and Why It Matters

Leo Eisner has just published a timely breakdown of the FDA’s December 22 update to the Recognized Consensus Standards Database—more than 100 standards added or revised, with several now eligible under the ASCA Program.

He highlights the IEC 60601 and 80601 series additions, explains how ASCA eligibility works inside FDA’s recognition framework, and brings attention to AAMI CR515:2025, which addresses cybersecurity considerations unique to machine-learning–enabled devices.

Learn:

• What changed
• Which standards are affected
• How those standards should flow into design inputs and regulatory strategy
• Why early alignment reduces rework later

Read the article >>

MLV | 2025 Year in Review

Yesterday I shared a snapshot of what we built together this year, and I want to pause here to thank everyone who has been part of it — the people who write, speak, join webinars, show up on Fridays, send notes, and share their work so openly.

This community grew because you contributed your time, your perspective, and your experience. What we published, covered, recorded, and learned this year reflects a shared effort, and I’m grateful for every person who helped shape it.

Thank you for reading, teaching, debating, and building alongside us.

Explore the Year in Review >>

📌 This Week’s Top Posts (In no special order)

• Robert van Boxtel underscored common audit misconceptions around ISO 13485 risk-based thinking.
• The EU MDR and IVDR reform proposal and its regulatory implications was overviewed by Angelina Lisandrelli.
• The 5-step process for authoring a regulatory submission, from source documents to CTD sections, was detailed by Rabiea.
• Danny Van Roijen highlighted the European Commission’s renewal of UK GDPR adequacy and its implications for cross-border data flows.
• DaeGuen Hwang reinforced the importance of clear impact analysis as a regulatory and professional obligation.
• New MDCG guidance clarifying post-market surveillance expectations for medical devices and IVDs was shared by Stefano Bolletta.
• In her weekly Monday update, Marina Daineko shared key EU MDR, IVDR, and ISO 10993-1 developments shaping biocompatibility and regulatory strategy.
• Intrinsic Medical Group contrasted competency expectations under ISO 10993-1:2018 vs 2025.
• The differences between FDA and EU MDR risk-based classification systems were broken down by Matrix One.
• The rise of PCCPs as a pathway for continuous AI algorithm improvement was underscored by Yujan Shrestha.
• Daniela Drago discussed the difference between statistical significance and clinical meaningfulness in a helpful video.
• EU Health and Food Safety announced the designation of four new EU Reference Laboratories to strengthen oversight of high-risk IVDs.

🗓️ Upcoming Events & Webinars

Friday In-Focus, January 2 — We restart the weekly series with a Year-in-Preview session led by Sean Smith, providing an overview of the regulatory, commercial, and visibility themes that will shape early 2026 for MedTech consultants and manufacturers. Register Now >>

Thursday, January 22, 2026 | 10:00 AM ET / 4:00 PM CET. 2026 Regulatory Roadmap: Key MDR & IVDR Compliance Prioritieswith Subject Matter Experts: Dr. Bassil Akra (AKRA Team), Erik Vollebregt (Axon Lawyers), Tom Patten (GMED) — A focused session on the milestones, pressures, and operational expectations shaping MDR and IVDR in 2026, including certificate renewal, PRRC oversight, clinical evidence pathways, and notified body interpretation trends. Register with one click >>

NEW 🔥 February 2–4, 2026 | Carlsbad, CA — Navigating Compliance for Medical Devices — Nemko & Eisner Safety Consultants - Three days of practical training on IEC 60601, EMC/RF, usability, software lifecycle, FDA/MDR expectations, and hands-on compliance workshops. Early-bird registration through December 31. Learn more >>

💥 Weekly 510(k) Roundup

December 22, 2025 | From Marcus Engineering, LLC

104 total clearances across multiple categories, including 20 first-time clearances(🚀)

• RefleXion Medical– SCINTIX Biology-Guided Radiotherapy: A radiotherapy system that uses PET radiotracer data to identify active tumors and guide radiation delivery in real time.
• Fisher & Paykel Healthcare – Optiflow Switch+ Nasal Interface: A high-flow nasal interface that provides oxygen therapy, CO₂ sampling, and filtered exhalation to support airway management and clinical monitoring.
• Topia MedTech – Alzevita Brain MRI Assistant: Cloud-based software that automatically segments the hippocampus on MRI and generates volumetric reports to support assessment of memory-related neurodegenerative conditions.

📋 Regulatory Roundup

December 22, 2025 Issue | By Martin King

This week’s regulatory activity reflects major shifts across medicines, medical devices, IVDs, advanced therapies, and digital health.

Key developments:

• EU MDR/IVDR simplification proposal signals a structural change for devices and diagnostics
• Ongoing IVDR fragility and diagnostics access risks highlighted
• Global movement toward risk-based, lifecycle oversight and increased use of RWE and patient-preference data
• Notified Body capacity, transparency, and predictability identified as policy priorities
• Digitalisation, AI governance, cybersecurity, and interoperability reinforced as baseline expectations
• Supply resilience, shortages, and preparedness increasingly embedded into legislation
• Pharmacovigilance and safety systems expanding in scope and data intensity

Explore the Issue >>

✅ In Case You Missed It

Last week, I shared a free 21-pageUsability Prep Kit & Workbook from the ClariMed team. If you’re planning 2026 HF work or tightening your documentation, it’s a solid resource worth bookmarking.

Check it out >>

🔥 Postscript

Happy New Year!

- Sean 🐝