The regulatory landscape for Software as a Medical Device (SaMD) has undergone a seismic shift in early 2026. With the FDA’s withdrawal of legacy 2017 guidances and the implementation of rigorous new frameworks for Clinical Decision Support (CDS) and AI-enabled lifecycle management, the “wait and see” approach is no longer viable. Middle and senior-level professionals must now navigate a complex environment where clinical evaluation is not a one-time event, but a continuous lifecycle requirement.

This webinar provides a high-level strategic roadmap for establishing Valid Clinical Association and Clinical Validation in this new era. We move beyond theoretical definitions to address the practicalities of Predetermined Change Control Plans (PCCPs) and the use of Real-World Evidence (RWE) to accelerate clearance. Attendees will gain the insights necessary to align software innovation with shifting FDA expectations, ensuring that product iterations remain compliant without compromising speed-to-market.

Topics to be Covered

1. The 2026 Pivot: Withdrawn Guidances & New CDS Boundaries

• Analysis of why the FDA withdrew the 2017 SaMD Clinical Evaluation guidance and what has replaced it.
• Navigating the updated Clinical Decision Support (CDS) framework: When does your software “step over the line” from a non-device tool to a regulated medical device?

2. The Three Pillars of Clinical Evidence (Modernized)

• Valid Clinical Association: Establishing the scientific “hook” between your software output and the clinical condition.
• Analytical Validation: Technical proof that your code reliably processes inputs.
• Clinical Validation: Generating robust evidence that the SaMD yields a meaningful positive impact on patient health.

3. AI & ML: Managing “Drift” and PCCPs

• Implementing the Predetermined Change Control Plan (PCCP): How to gain FDA clearance for future software updates before you make them.
• Addressing “Model Drift”: Regulatory expectations for continuous monitoring and performance re-validation in 2026.

4. Leveraging Real-World Evidence (RWE) for 510(k) and De Novo

• Strategic use of curated databases and post-market data to supplement or replace traditional clinical trials.
• FDA expectations for data integrity, bias mitigation, and “Generalizability” across diverse patient populations.

5. Human Factors in SaMD Evaluation

• Why the user interface is now considered a “clinical” component: Validating that the clinician or patient can correctly interpret and act upon software outputs without error.

Why Should You Attend?

The cost of a regulatory miscalculation in the SaMD space is measured in years of delay and millions in lost revenue.

• Avoid Enforcement Actions: Understand the FDA’s 2026 stance on “Wellness” claims. Learn from recent warning letters (e.g., WHOOP) where labeling triggered unintended device classification.
• Streamline Your Submission: Identify the exact type of clinical data needed for your specific SaMD category (Screening vs. Diagnosis vs. Treatment) to avoid “Request for Additional Information” (AI) holds.
• Master AI Compliance: If your SaMD uses machine learning, you must understand the 2026 Final Guidance on AI-Enabled Device Software Functions. We explain the mandatory transparency and labeling requirements.
• Optimize Budgeting: Learn when a small-scale “Early Feasibility Study” is sufficient and when a statistically powered pivotal trial is non-negotiable.

Who Will Benefit?

This session is designed for professionals who are responsible for product strategy and clearance:

• Managers, VPs and Directors of Regulatory Affairs: To lead global digital health strategy.
• Heads of Clinical Affairs/Operations: To design “lean” clinical validation programs that satisfy FDA reviewers.
• Software CTOs & Product Leads: To align technical roadmaps with “Regulatory by Design” principles.
• Medical Device Professionals
• Quality Assurance Managers: To integrate the latest software lifecycle standards (IEC 62304) with clinical evaluation requirements.
• Legal Counsel: To mitigate risks associated with off-label software claims and data privacy in clinical studies.

Exclusive Takeaways

1. The 2026 SaMD “Device vs. Wellness” Decision Matrix: A tool to determine if your software functions fall under FDA enforcement discretion.
2. PCCP Template Outline: A strategic guide for drafting your Predetermined Change Control Plan for AI updates.
3. Clinical Evidence Gap Analysis: A checklist for auditing your current validation data against the latest IMDRF and FDA expectations.