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.
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.
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.
The FY 2026 guidance priorities reflect several strategic themes:
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
Comments should be clear, concise, and reference specific sections. Including proposed edits or rationale strengthens the feedback.
While CDRH aims to publish all A- and B-list documents, several factors can delay or prevent publication, including:
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:
Prepare documentation that anticipates regulatory shifts.
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.
Contact us for a free consultation and let’s build your compliance roadmap together.