FDA Strategy 2025: What's Really Happening

October 5, 2025 | Issue 132 — US Government Shutdown

Your weekly source for medical device regulatory intelligence

📝 From the Editor

A little egg on my face last Friday—but we're back stronger.

Join us this week for Miguel Amador and Célia Cruz on AI insights from Portugal (Friday, 11 am ET), and mark your calendar for Robert van Boxtel and Jelle Schrauwen on SotA, Claims & Strategy (October 17th).

The regulatory world keeps spinning at breakneck speed.

This week: The FDA's regulation freeze creates a 2-3 year competitive advantage for those with de novo approvals in hand, the EU grapples with MDR reality checks, showing 24-month CE marking timelines, and Malaysia joins MDSAP, while South Africa mandates ISO 13485.

Recent replays worth catching:Human Factors Engineering with Kay Sim on why usability matters from day one, and our EU AI Act Countdown, breaking down what MedTech companies need to do before 2027.

The pace of change isn't slowing—but neither are we.

—Sean Smith, Founder & Publisher

🎯 Quick Hits: This Week's Top LinkedIn Posts (in no special order)

• EMA Patient Experience Data - Danny Van Roijen on new reflection paper emphasizing patient data across entire medicine lifecycle
• EU AI Act Compliance - Sigrid Berge van Rooijen's 10-step healthcare organization roadmap
• MedTech Europe Clinical Evidence - Stefano Bolletta highlights 4th edition updates for CDx, NGS, and RWE
• U.S. Import Probe Impact - Marina Daineko's weekly roundup on tariff threats and regulatory reforms
• Biological Evaluation Framework - Intrinsic Medical Group maps 8 phases, 30 steps for compliance
• Trend Detection Cheat Sheet - Tibor Zechmeister on CUSUM, P-Charts, and early signal detection
• Annex VI MDR Pitfalls - Dr. Pallavi Dasgupta reveals registration hurdles often overlooked
• 7 Compliance Game-Changers - Bastian Krapinger-Ruether challenges the $5B cost of non-compliance
• Cybersecurity Postmarket Guide - Jose Bohorquez shares Chapter 5 on perpetual vulnerability management
• ISO/CD 18969 Standard 🚀 - Ola Konopka introduces new clinical evaluation harmonization
• EU CE Mark Reality Check 🚀 - Jon I. Bergsteinsson exposes 15-24 month timelines vs. 12-month myths

🔥 This Week's Top Story

FDA Strategy 2025: What's Really Happening

Michelle Lott and Tianna Benson from leanRAQA delivered critical insights in their October 3rd webinar on FDA's evolving regulatory landscape. Key takeaways include:

• The Regulation Freeze Impact: De novo approvals are stalled with no published special controls, creating a 2-3 year competitive advantage for companies with 2025 de novos
• Government Shutdown Reality: No new FY26 submissions accepted, no establishment fees, everything frozen except already-paid FY25 submissions
• ELSA AI Tool Concerns: FDA reviewers may rely on this tool without fully understanding its limitations - a "special 510(k)" designation raises red flags
• Communications Crisis: The FDA communications department has been laid off, with guidance updates now found on LinkedIn rather than official channels
• What's Still Working: 510(k) reviews averaging 127 days, pre-sub meetings on schedule, and QMSR transition proceeding despite staff reductions

Watch replay | Download slides

📋 This Week's Essential Updates

1. EMA Elevates Patient Experience Data

Danny Van Roijen summarized the European Medicines Agency's groundbreaking reflection paper emphasizing systematic inclusion of patient experience data across the entire medicine lifecycle - from non-clinical research through post-marketing surveillance. The agency calls for high-quality, validated methodologies that reflect patient priorities. Feedback deadline: January 31, 2026

2. EU AI Act Compliance Roadmap

Sigrid Berge van Rooijen delivered a crucial 10-step infographic for healthcare organizations navigating the EU AI Act. Key requirements include:

• Risk assessment and classification of all AI systems
• Continuous monitoring with detailed record-keeping
• Vendor compliance verification
• Human oversight protocols
• Fundamental rights impact assessments
• Incident detection and reporting systems
• Comprehensive user training programs

3. MedTech Europe Updates Clinical Evidence Guidance

Stefano Bolletta announced the 4th edition of MedTech Europe's clinical evidence e-book, with significant updates to:

• Chapter 7: Companion Diagnostics
• Chapter 14: Next Generation Sequencing (NGS)
• Chapter 15: Real-World Evidence

🔍 Regulatory Intelligence

U.S. Import Investigation Shakes MedTech Markets

Marina Daineko reports on the Commerce Department's Section 232 investigation into medical device imports, causing immediate stock drops for companies with global supply chains (GE HealthCare, Stryker, Intuitive Surgical). The probe could trigger tariffs or import restrictions, potentially disrupting established supply chains and pressuring margins.

EU MDR Timeline Reality Check

Jon I. Bergsteinsson delivers a sobering assessment of actual CE marking timelines:

• Class IIa devices: 15-18 months from submission to certificate
• Class IIb devices: 18-24 months average, often longer
• Critical factor: Securing Notified Body capacity early - without it, your "12-month plan" is fiction

Dr. Pallavi Dasgupta highlights Annex VI as the "hidden hurdle" in MDR compliance, where even well-prepared companies stumble during device and economic operator registration. Her visual guide provides a practical checklist for avoiding common pitfalls.

🛠️ Technical Excellence

Biological Evaluation Mastery

Intrinsic Medical Group breaks down the complete biological evaluation process into 8 phases and 30 precise steps:

1. Plan the evaluation (scope, device, risks, experts)
2. Gather & characterize data (chemistry, hazards, literature, PMS)
3. Run gap analysis
4. Define strategy (TRA, in vitro testing first, justified waivers)
5. Execute studies
6. Evaluate & conclude (residual risk vs. benefit)
7. Report (BER with evidence & expertise)
8. Continuous review (PMS, changes, updates)

Cybersecurity Postmarket Responsibilities

Jose Bohorquez shares Chapter 5 of his medical device cybersecurity book, emphasizing that security responsibilities never end post-FDA clearance. Key vulnerability discovery methods include:

• SBOM Analysis
• ISAC/ISAO reports
• Periodic penetration testing
• Coordinated vulnerability disclosure
• Internal/customer anomaly reports

📊 Quality & Compliance

Trend Analysis That Actually Works

Tibor Zechmeister provides a practical framework for trend detection and action:

Watch for these signals:

• Statistically meaningful increases
• No clear root cause
• Recurring patterns across time, batches, or markets

Detection tools to deploy:

• CUSUM: Detects slow, creeping changes
• P-Charts: Reveals complaint rate shifts
• Regression: Surfaces long-term trends
• Poisson models: Makes rare but serious events visible

Fast action protocol:

1. Verify data (remove bias and duplication)
2. Investigate scope (isolated vs. systemic)
3. Update risk files (ISO 14971 alignment)
4. Escalate if needed
5. Document everything

Compliance as Competitive Edge

Bastian Krapinger-Ruether challenges the traditional view of compliance, citing McKinsey's $5B annual non-compliance cost estimate. His 7 strategies for revolutionizing compliance:

• Make it strategic, not checkbox
• Automate tedious tasks
• Harness real-time data
• Stay ahead of regulatory changes
• Simplify audits
• Boost post-market surveillance
• Build a compliance culture

🆕 Standards Development

ISO/CD 18969: New Clinical Evaluation Standard

Ola Konopka introduces ISO/CD 18969, designed to harmonize clinical evaluation practices globally. This new standard aims to:

• Bridge regulatory requirements with practical evaluation methods
• Standardize clinical evidence approaches
• Better integrate with risk management and PMS/PMCF
• Supplement existing MEDDEV and MDCG guidance

Currently at Committee Draft stage, moving to Draft International Standard for public consultation

📅 Upcoming Events

RAPS Convergence 2025

October 5-8, 2025 • San Diego, CA The premier regulatory affairs conference returns with essential sessions on global harmonization, AI/ML device pathways, and expedited approval strategies. Don't miss the FDA town halls and interactive workshops. MedTech World serving as media partner

Friday In-Focus: Portugal AI Unconference Insights

October 10, 2025 • 11:00 AM ET • Virtual Miguel Amador and Célia F. Cruz share key takeaways from last week's Portugal "AI and MedTech Unconference" — including survey results on AI adoption, practical frameworks for continuous compliance, and a uniquely Portuguese perspective on regulatory transformation. Register: MLV Exchange

Friday In-Focus: State of the Art (SotA) and Strategy

October 17, 2025 • 11:00 AM ET • Virtual Robert van Boxtel and Jelle Schrauwen explore how to bridge clinical claims, regulatory expectations, and business strategy. Moving beyond documentation to build robust, forward-looking approaches. Register: MLV Exchange

Due Diligence for MedTech Investors

October 22, 2025 • 11:00 AM ET • Virtual Renae Franz of leanRAQA demystifies the due diligence process for MedTech investments, covering regulatory red flags, quality system assessment, and strategic evaluation frameworks. MLV Webinar, registration coming soon!

TEAM-PRRC Annual Summit

October 23-24, 2025 • Rome, ItalySOLD OUT! Celebrating 5 years of TEAM-PRRC with 100 attendees, featuring speakers from MedTech Europe, Italian authorities, BV MED, and roundtables with 5 notified bodies (BSI Italy, IMQ, TÜV SÜD, Kiwa Cermet, Bureau Veritas). As Bassil Akra noted:

"2025 is where we'll see the proposal for MDR changes — having stakeholders together to discuss current experience and future developments is crucial."

Conducting MedTech Pre-Market Clinical Studies in the EU Masterclass

October 29, 2025 • Virtual Daniela Karrer and Matteo Mosso from Donawa Lifescience provide comprehensive guidance on navigating EU clinical study requirements, from protocol design through regulatory submission. MLV Webinar, registration coming soon!

MedTech Malta 2025

November 12-14, 2025 • Valletta, Malta MedTech World's flagship summit returns to the Mediterranean Conference Centre, expecting 2,000+ attendees. Features the StartUp Pitch competition, MedTech World Awards gala, and confirmed speakers including Malta's Prime Minister, Ken Nelson (MedTech Advantage Fund), and Diana Saraceni (Panakes Partners). Early Bird Registration Now Open: Learn More.

eIFU and Labeling Panel Discussion

November 30, 2025 • Virtual AKRA TEAM expert panel addresses the evolving landscape of electronic Instructions for Use and labeling requirements across global markets, including practical implementation strategies and regulatory compliance tips. MLV Webinar, registration coming soon!

💭 Weekly Reflections

From Martin King's Regulatory Roundup (September 29)

This week's global regulatory landscape reveals significant shifts across multiple jurisdictions:

EU Updates: The Commission's introduction of "Master UDI-DI" for spectacle devices promises to reduce administrative burden, while new guidance on explainable AI in cardiovascular health addresses critical transparency needs. Healthcare inequality reports show the dual challenge of reducing disparities while managing affordability.

Asia-Pacific Developments: Malaysia's MDSAP membership marks a significant step toward regulatory harmonization, potentially accelerating market access for manufacturers with existing MDSAP certifications. China's NMPA released 15 new device standards, signaling continued regulatory evolution in one of the world's largest markets.

FDA's Expanding Guidance: Six new FDA guidances this week demonstrate the agency's commitment to innovation pathways, particularly in regenerative medicine and AI/ML-enabled devices. The Computer Software Assurance guidance's risk-based approach should reduce validation burden for lower-risk software.

Key Takeaway: The regulatory environment continues to evolve rapidly across all major markets. Success requires not just compliance, but strategic anticipation of these changes.

From Marcus Engineering's 510(k) Roundup (September 29)

Weekly 510(k)Stats:

• Total clearances: 65 devices across 15 categories
• Average review time: 152 days (varies significantly by category)
• Notable first-time 510(k) recipients: 8 companies marked with 🚀

This Week's Innovation Highlights: Marcus spotlighted three groundbreaking clearances that showcase MedTech thinking outside the box:

• Levita Magnetics' MARS Platform: Magnetic surgery system that manipulates tools from outside the body, reducing incisions
• Tuned's Self-Fitting App: Hearing aid adjustment via smartphone, eliminating office visits
• Boston Scientific's LithoVue Elite: Ureteroscope with real-time kidney pressure monitoring to prevent damage during stone procedures

Review Time Insights:

• Fastest: Dental device cleared in just 1 day (Hangzhou Shining3D's Dura-Crown)
• Longest: General surgery diagnostic device at 300 days
• The wide variation underscores the importance of proper submission preparation

Marcus's Take: "From magnetic mastery in the OR to hearing care that fits in your pocket and scopes that think on the job—the future of medtech isn't just coming, it's already in the room."

🎯 The Bottom Line

This week's developments underscore a MedTech industry in transition.

While FDA faces unprecedented operational challenges with frozen regulations and laid-off communications staff, the EU continues building its regulatory framework with new standards and AI requirements.

The message is clear: success in 2025's MedTech landscape requires:

• Realistic timeline planning (especially for EU market entry)
• Proactive compliance strategies that create competitive advantage
• Robust trend detection and response systems
• Early engagement with evolving standards and guidance

Companies that view compliance as strategic enabler rather than burden will find themselves best positioned to navigate these turbulent regulatory waters.

Have insights to share? Spotted a critical update? Reply to contribute to next week's issue.

Stay vigilant, stay compliant, stay ahead.

- Sean