The Food and Drug Administration on Tuesday published a prioritized list of guidance documents the agency’s Center for Devices and Radiological Health (CDRH) plans to develop or publish in the federal government’s fiscal 2026 year, reaffirming several items carried over from last year and highlighting capacity limits that could slow additional work.

Among the four final guidance topics the agency identified as top priorities are finalization of guidance on the use of real‑world evidence (RWE) to support regulatory decisions and on predetermined change control plans (PCCPs) for medical devices. The agency also named air‑purifying respirators and menstrual products among its leading draft guidance priorities, noting that three of the four draft topics are holdovers from the 2025 list.

In a statement accompanying the list, the FDA emphasized that "guidance documents represent the agency’s current thinking on a topic and are intended to provide clarity to stakeholders," and added that it will pursue additional guidance development "if it has the resources to do so." That conditional language underscores ongoing concerns about workforce and budgetary constraints across regulatory programs as device innovation accelerates.

Regulators and industry watchers said the emphasis on RWE and PCCPs reflects the agency’s effort to modernize oversight for devices that evolve after market clearance. Real‑world evidence — data collected from routine clinical care, registries and electronic health records — has been championed as a way to broaden evidence beyond traditional clinical trials, particularly for rare conditions or iterative technologies. PCCPs, a mechanism for pre‑agreeing to certain planned device modifications, aim to streamline approvals for predictable changes, such as software updates or component swaps, without requiring case‑by‑case submissions.

"The potential of clearly articulated RWE and change‑control pathways is to reduce uncertainty for manufacturers while maintaining patient safeguards," said a senior device industry analyst who requested anonymity. "But success will depend on detailed standards for data quality and specific examples."

The return of guidance on air‑purifying respirators reflects continued attention to respiratory protection standards that surged during the COVID‑19 pandemic. Clearer respirator guidance could influence both domestic manufacturing and procurement decisions for hospitals and federal preparedness stockpiles. Guidance on menstrual products — which the FDA has signaled interest in previously amid consumer concerns about safety, toxic shock syndrome and ingredient transparency — aims to codify testing and labeling expectations for a widely used class of consumer medical devices.

Stakeholders will have opportunities to comment on draft documents, an avenue industry groups and patient advocates are expected to use to shape implementation. The FDA’s roadmap, while not legally binding, provides a forecast of the regulatory environment companies and health systems will navigate over the coming year.

As the agency moves forward, its conditional commitment to additional guidance if resources permit will be closely watched. Regulators must balance the pace of guidance development with the need for rigorous public engagement and technical detail, decisions that will affect how quickly innovations reach patients and how safely iterative device changes are managed after market entry.