January 07, 2026

The U.S. government’s Fiscal Year 2026 began on October 1, and with it the FDA’s Center for Devices and Radiological Health (CDRH) released its updated plan outlining which guidance documents it intends to publish or advance this year. The plan is structured into three priority tiers:

  • A-List – High-priority guidance documents intended for publication within FY2026
  • B-List – Guidance documents the FDA will work on if resources allow
  • Under Construction (UC) – Lower-priority topics that remain in development

For manufacturers preparing new devices or maintaining compliance within the U.S. market, the CDRH’s annual roadmap provides critical insights into regulatory expectations, emerging requirements, and areas undergoing significant policy evolution.

Summary of CDRH Planning Structure for FY2026

A-List – Highest Priority Guidance (To Be Published This Year)

There are eight guidance documents on the FY2026 A-List.

Key topics expected to influence many manufacturers include:

1. Device Software Functions (Draft)

  • Updated approach to software classification
  • Broader implications for SaMD, SiMD, and digital health tools

2. Quality Management System Information for Premarket Submissions (Draft Published FY2026)

  • Aligns with FDA’s transition toward ISO 13485-based QMSR
  • Will affect nearly all 510(k), PMA, PDP, and De Novo submissions

3. Real-World Evidence Revision

  • Updated expectations on RWE study design
  • Growing role in premarket and post market decisions

4. Validation of Diagnostic Tests for Emerging Pathogens

  • Critical for responding rapidly to public health threats
  • Builds on draft published in FY2025

Other A-List topics signal expanded oversight in:

  • Digital health
  • Diagnostic performance
  • Quality documentation
  • Clinical evaluation

B-List – Development as Resources Allow

There are three B-List guidance documents for FY2026.

The most notable entry:

Artificial Intelligence (AI) Lifecycle Management – Final

  • Builds on the FY2025 draft
  • Expected to clarify the FDA’s expectations for AI/ML-enabled software
  • May define real-time algorithm changes, data drift monitoring, and documentation

Additional B-List topics include:

  • Weight-loss medical devices
  • Human factors content for submissions

These areas align with rapidly growing product segments and heightened FDA scrutiny.

Under Construction (UC) – Long-Term Guidance Topics

The FY2026 UC list contains nine guidance items.

Noteworthy topics include:

1. Intended Use of Medical Devices

Two separate guidance documents relate to intended use, including substantial equivalence limitations critical for 510(k) strategy.

2. Evaluation of Thermal Effects

Thermal risk is a broad concern for energy-based devices, wearables, sensors, and implants.

3. Robotically Assisted Surgical Devices

Reflects expanding FDA oversight on surgical robotics and next-generation surgical automation technologies.

Comparing FY2025 vs. FY2026 Guidance Plans

Understanding shifts between years offers valuable regulatory forecasting.

Key highlights:

  • Only 35% of FY2025 A-List guidance documents were published as planned
  • About 28% of B-List and UC-List documents saw progress
  • 34 guidance documents published in FY2025 were not included in the original plan, representing 81% of all publications

What This Means:

The FDA’s annual plan is directional, not definitive.
 Manufacturers must maintain proactive regulatory intelligence because:

  • High-priority topics can shift
  • Emerging technologies accelerate new guidance
  • Public health needs to influence regulatory actions
  • Market events and safety concerns can reprioritize CDRH resources

Key FY2026 Guidance Documents Likely to Impact Most Manufacturers

1. Software Functions in Medical Devices

Growing oversight of software-intensive products, including:

  • AI/ML algorithms
  • Connectivity features
  • Software-as-a-Medical-Device (SaMD)
  • Cybersecurity controls

2. QMS Information for Premarket Submissions

Critical for:

  • 510(k)
  • De Novo
  • PMA

industry prepares for the upcoming Quality Management System Regulation (QMSR) transition.

3. AI-Enabled Software

Defines the lifecycle framework for AI products, including:

  • Algorithm training
  • Post-market change protocols
  • Validation standards
  • Real-world monitoring

4. Intended Use Updates

Affects how manufacturers justify substantial equivalence, label claims, and device classification.

5. Thermal Effects Evaluation

Important for:

  • Wearables
  • RF devices
  • Energy-based surgical tools
  • Consumer health tech

Why These Updates Matter for Manufacturers

  • Submission requirements may change
  • Technical documentation expectations will increase
  • AI-related products may face new lifecycle obligations
  • Transparency and traceability requirements are rising
  • More emphasis on risk-based, real-world data-supported decisions

Proactive alignment with FY2026 priorities ensures:

  • Faster submission acceptance
  • Reduced deficiency responses
  • Smoother Q-Submission interactions
  • Better long-term compliance

Staying Ahead: What Companies Should Do Now

  • Monitor FDA updates weekly
  • Review A-List topics against your device portfolio
  • Evaluate whether upcoming guidance impacts devices in development
  • Strengthening documentation around software, cybersecurity, and QMS
  • Align early with AI guidance for ML-based products
  • Prepare for evolving intended use expectations

The CDRH often publishes guidance not listed in its plan, making continuous monitoring essential.

Conclusion

The FDA CDRH FY2026 plan signals major focus areas for:

  • Software-driven devices
  • AI-enabled technologies
  • Diagnostic performance
  • Quality management system alignment
  • Improved consistency in premarket submissions

With only 35% of planned guidance published in FY2025, it is critical for manufacturers to adopt dynamic and proactive regulatory intelligence strategies.

Staying ahead of these changes is essential for ensuring device readiness, market compliance, and regulatory success.

How Maven Regulatory Solutions Supports FDA Device Strategy

Maven Regulatory Solutions provides comprehensive U.S. Regulatory Affairs support to help companies prepare for evolving CDRH expectations.

Our Expertise Includes:

  • 510(k), De Novo, and PMA regulatory strategy
  • Q-Submission support and FDA meeting preparation
  • QMS documentation for QMSR-aligned submissions
  • Software and AI/ML regulatory pathways
  • Labeling, UDI, and intended use compliance
  • Regulatory intelligence tracking and impact assessments
  • Gap analysis for CDRH guidance updates
  • End-to-end U.S. market entry support

Maven ensures manufacturers remain fully aligned with FDA expectations for FY2026 and beyond.