ISO 10993-1:2025 Published Despite FDA Opposition

MedTech Leading Voice | Issue 139

ISO 10993-1:2025 Published Despite FDA Opposition: Mandatory Risk Integration and Device Recategorization Create Immediate Compliance Challenges

📝 From the Editor

Biocompatibility testing enters a new compliance framework with ISO 10993-1:2025.

ISO 10993-1:2025 was published in November despite FDA and AAMI opposition, introducing mandatory risk estimation throughout device lifecycles and full ISO 14971 integration. Device categories restructured, cumulative exposure expanded to include reasonably foreseeable misuse, and biological evaluation plans now required as documented deliverables. Manufacturers face immediate challenges: new requirements conflict with existing FDA draft guidance, risk scoring methodology remains undefined, and implementation guidance won't arrive until after the standard takes effect.

Don't miss: Breakthrough Device Designation in the EU (December 4, 10:00 a.m. ET / 4:00 p.m. CET) with Dr. Donal O'Connor, Matthias Fink, Dan Kosednar, and Richard Holborow revealing the new regulatory pathway and market access strategy.

This week: ISO 10993-1 transition requirements, EU breakthrough device designation pathways, software verification failures, and France's AI health strategy. Plus, China's updated NMPA cleanroom standards and 38 new 510(k) clearances.

— Sean Smith, Founder & Publisher

🎯 Featured Event

Don't miss this one! Breakthrough Device Designation in the EU: A New Regulatory and Market Access Pathway Thursday, December 4, 2025 | 10:00 AM ET / 4:00 PM CET | Presented by MedTech Leading Voice and AKRA TEAM | Register Now >>

Four leading regulatory and clinical experts explore the new EU breakthrough device designation pathway—comparable to FDA's program—addressing accelerated assessment procedures, clinical evidence expectations, and market access strategy across member states.

📚 Featured Posts This Week

1. In a popular post, Marina Daineko announced the publication of ISO 10993-1:2025 in a popular post • Confirms the standard is now available and represents the first major revision in seven years • Marks regulatory milestone requiring manufacturers to reassess biological evaluation approaches
2. Swetha Ravichandiran also announced ISO 10993-1:2025 publication, noting FDA and AAMI voted against the revision • Highlights mandatory risk estimation throughout device lifecycle, restructured device categories, and full ISO 14971 integration • Identifies key red flags: conflicts with FDA draft guidance, undefined risk scoring methodology, chemical characterization challenges with common polymers, and publication before comprehensive implementation guidance exists • Signals immediate need for gap analysis on existing biological evaluation reports and device category remapping

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

• Mike B. Wetherington revealed 3 reasons why software verification fails, pointing to weak traceability between requirements, testing, and risk controls.
• France’s new AI and health data strategy (2025–2028) was detailed by Danny Van Roijen, highlighting key reforms in governance and AI use in healthcare.
• Sigrid Berge van Rooijen compiled 5 key risks of bias in AI healthcare, warning flawed data can distort outcomes and impact patient safety.
• Adam Isaacs Rae discussed key soft skills essential for effective medical device auditing in his recent newsletter.
• Sara Moeller summarized a recent FDA warning letter on improper CRO obligation transfer.
• Marina Daineko announced the publication of ISO 10993-1:2025 in a popular post
• A 5-layer framework for organizing a MedTech QMS was outlined by Darrin Carlson.
• Tibor Zechmeister overviewed 6 essential sections to include in all Intended Purpose documents.
• 16 key FDA regulations were shared by Srinivas A., consisting of a snapshot of the most essential CFR parts.
• Mitali M. broke down EU MDR clinical evaluation and its key requirements in a helpful post 
• A helpful article on applying AI within the CAPA process was written and published by Manfred Maiers.
• Elaine T. outlined China’s updated NMPA GMP cleanroom pressure requirements ahead of their 2026 enforcement.
• Dr. Zhong Wei Khor rounded up notable healthtech accelerators across Europe in a helpful infographic.

🗓️ Upcoming Events & Webinars

Breakthrough Device Designation in the EU: A New Regulatory and Market Access Pathway | Thursday, December 4, 2025 | 10:00 AM ET / 4:00 PM CET | Presented by MedTech Leading Voice and AKRA TEAM. The MDCG introduces a breakthrough device designation pathway to accelerate patient access to transformative innovations. Join expert panel: Dr. Donal O'Connor (Clinical Manager, Medical Devices, Health Products Regulatory Authority, Ireland), Matthias Fink (Senior Clinical Consultant, AKRA TEAM GmbH, Germany), Dan Kosednar (Vice President, Regulatory Affairs, HistoSonics, Inc., USA), Richard Holborow (Head of Clinical Compliance, BSI Group, UK). Register Now

How to Become a Lead Auditor for Software as a Medical Device | Wednesday, December 17, 2025 | 3:00 PM ET | Presented by MedTech Leading Voice and Medical Device Academy. Join subject matter expertRob Packard (President, Medical Device Academy) covering SaMD audit leadership scope and responsibilities, how to plan, conduct, report, and follow up audits for software devices, what changes with FDA's QMSR, and how to prepare teams on deadline, and templates/checklists and practice tips that shorten time to competence. Register Now

💥 Weekly 510(k) Roundup

November 17, 2025 | From Marcus Engineering, LLC

38 total clearances across 12 categories, including 11 first-time clearances (🚀)

Medical Microinstruments– Symani Surgical System (K252287) Robotic microsurgery platform with 20× movement scaling and tremor filtering enables surgeons to stitch blood and lymph vessels thinner than a human hair. Named one of TIME's Best Inventions for breakthrough precision in sub-millimeter vessel anastomosis. (110 days, -21 days)

Withings– BeamO (K252474) All-in-one home health scanner integrates temperature, ECG, pulse oximetry, and digital stethoscope. No wires, no white coat needed. Brings clinic-grade insights to remote chronic disease management and telehealth visits with real data. (96 days, -52 days)

Philips– IntelliVue MX750 / MX850 (K251702) Advanced hospital monitoring systems with smart alarm algorithms, bedside EMR integration, and built-in cybersecurity. Helps care teams catch subtle changes earlier in critical care environments when every second matters. (161 days, +13 days)

📋 Regulatory Roundup

November 17, 2025 Issue | By Martin King

• EU: EMA's digital transformation and AI-driven data governance
• National: MHRA (UK), HPRA (Ireland), Medical Device Authority Malaysia, Swissmedic (Switzerland), TGA (Australia) — operational updates and compliance guidance
• Standards: Team-NB MDR/IVDR initiatives and harmonized standard updates
• Global: ICH and WHO global harmonization themes, EDQM and Council of Europe operational updates
• Cross-Cutting Trends: Global convergence on digital tools, evidence harmonization, and ethics-based oversight; MedTech Europe's sustainability initiatives; capacity and legacy-device shortages remain critical risks for industry compliance and patient access

"Global regulators are converging on digital tools, evidence harmonisation and ethics-based oversight, while capacity and legacy-device shortages remain critical risks for industry compliance and patient access. From EMA's digital transformation and AI-driven data governance to MedTech Europe's sustainability push, this month marks a clear acceleration in global convergence."

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