EU – Eisner Safety Consultants

Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards

Key themes: IEC 60601/80601, IEC 61326-2-6, ISO 15223-1 A1:25, & ASCA considerations

In late December 2025, the FDA expanded its Recognized Consensus Standards Database, adding more than 100 new or updated standards. Some are eligible for use under the ASCA Program, while others carry important implications for design, testing, labeling, and overall regulatory strategy.

Regulatory expectations around standards are shifting earlier in the product lifecycle. Standards are no longer something teams can simply “handle at test.” Reviewers increasingly expect standards interpretation, risk decisions, and test strategies to be visible and justified during design reviews and technical documentation development. This reinforces why understanding not just which standards are recognized, but how they are recognized and applied, matters more than ever.

Medical Device Compliance & Certification Summit – Why It Matters?

Medical device and diagnostic compliance expectations are shifting earlier in the product lifecycle. IEC 60601 and related standards are no longer something teams can “handle at test.” Regulators increasingly expect standards interpretation, risk decisions, and test strategy to be visible and justified during design reviews and technical documentation development.

This shift is showing up in real ways – through tougher design reviews, deeper questions during pre-submission interactions, and increased scrutiny of how standards were applied, not just whether a final test report exists.

To address this reality, Eisner Safety Consultants (ESC) is working with Nemko to deliver a three-day, in-person Medical Device Compliance & Certification Summit focused on how standards, testing, and regulatory expectations intersect in real programs.

This is a focused, three-day program for engineering, regulatory, and compliance teams navigating IEC 60601, IEC 61010, EMC and RF requirements, certification strategy, and regulator guidance documents across FDA, EU, and other markets.

Major changes to IEC 60601-1 are closer than you think

Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines

Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions

Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.

Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays

Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting 📣📣

👉 ISO TC 210 WG2 met in Tokyo, Japan 🇯🇵 on 4 – 5 March 2025. 👉 WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed. Changes proposed: 👉 Add reference

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