Key Insights from FDA CDRH’s FY 2026 Guidance Priorities

The FDA’s CDRH just revealed its regulatory playbook for FY 2026, and if you're a medical device manufacturer, it's time to pay attention. From AI-enabled diagnostics to patient preference data, the agency’s planned guidance documents signal where innovation meets oversight. Understanding these priorities now can mean the difference between leading the market or lagging behind.

CDRH and Its Role in U.S. Medical Device Regulation

The Center for Devices and Radiological Health (CDRH) is a branch of the FDA that oversees the safety, effectiveness, and quality of medical devices and radiation-emitting products to protect patients and support healthcare providers. CDRH supports medical device innovation by offering science-based guidance that helps manufacturers prepare, submit, and monitor devices marketed in the U.S. with greater transparency and consistency.

CDRH issues FDA guidance documents to clarify regulatory expectations and promote consistent, science-based decision-making for medical device manufacturers. These documents help industry stakeholders understand how to meet safety, effectiveness, and quality standards throughout the device lifecycle.

Each year, CDRH publishes a list of guidance documents it plans to issue or develop. These documents are not legally binding, but they reflect the FDA’s current thinking and are essential tools for regulatory strategy.

Overview of CDRH's FY 2026 Guidance Lists

A-List

High-priority guidance documents CDRH intends to publish this fiscal year.

B-List

Guidance documents CDRH aims to publish as resources permit in FY 2026.

Under Construction

Guidance documents, not on the A- or B- Lists, that CDRH intends to develop as resources permit.

View Full Guidance Lists Here | Download the FY 2026 PDF

Why CDRH Publishes Annual Guidance Agendas

CDRH's annual guidance agenda reflects the FDA's commitment under the Medical Device User Fee Amendments (MDUFA) of 2012 (MDUFA III), 2017 (MDUFA IV), and 2022 (MDUFA V), where the FDA committed to a series of performance goals, both quantitative and qualitative, aimed at improving the efficiency of bringing safe, effective medical devices to market.

By publishing these lists annually, the agency promotes transparency, invites public feedback, and helps manufacturers plan ahead. It also allows stakeholders to suggest new topics or revisions to existing guidance documents.

Key Themes in the FY 2026 CDRH Priorities

The FY 2026 guidance priorities reflect several strategic themes:

Real-World Evidence (RWE): Guidance on using RWE to support regulatory decisions.
Predetermined Change Control Plans (PCCPs): Frameworks for managing device modifications.
Patient Preference Information: Incorporating voluntary patient input across the product lifecycle.
AI-Enabled Devices: Lifecycle management and marketing submission recommendations.
Software Function Policy Updates: Revisions to mobile medical application oversight.
Menstrual Product Safety: Labeling and performance testing guidance in response to health concerns.
Digital Mental Health Devices: Clinical evidence expectations for behavioral therapy technologies.

How to Submit Public Comments on the Guidance List

CDRH invites the public to submit comments, particularly on the relative importance of the guidance topics listed on the A-List and B-List.

The public may submit comments on the CDRH Fiscal Year 2026 Guidance Development until December 1, 2025

Electronically via Regulations.gov
Written submissions to the FDA’s Dockets Management Staff

Comments should be clear, concise, and reference specific sections. Including proposed edits or rationale strengthens the feedback.

Why Some Guidance Documents May Be Delayed

While CDRH aims to publish all A- and B-list documents, several factors can delay or prevent publication, including:

Resource constraints
Shifting public health priorities
Staff reallocation to urgent regulatory reviews
Evolving scientific or policy landscapes

What FY 2026 Means for Medical Device Manufacturers

Manufacturers should view the FY 2026 guidance agenda as a strategic signal. Whether you're developing AI-enabled software, navigating 510(k) submissions, or exploring patient-centric design, these documents will shape expectations and review standards.

Proactive steps for medical device manufacturers to take:

Align product development with upcoming guidance themes.
Monitor updates and comment opportunities.
Prepare documentation that anticipates regulatory shifts.

How Rook Quality Systems Can Help You Prepare

At Rook Quality Systems, we specialize in helping medical device companies stay ahead of regulatory changes. From gap assessments and submission preparation to risk assessments and audit-ready documentation, our team of Certified Quality Auditors and Quality Engineers is ready to support your compliance journey through FY 2026 and beyond.

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What’s Ahead for Medical Device Regulation: CDRH 2026 Guidance Priorities