The Food and Drug Administration released its prioritized list of medical device guidance documents for fiscal 2026 on Monday, underscoring continued regulatory attention to air purifying respirators, menstrual products and the evolving landscape of software in medical devices. The agency said the selection of topics reflects both public-health priorities and the technological trends reshaping device development.

In an agency statement, the FDA described the guidance plan as an effort to "provide clarity and predictability" to manufacturers and other stakeholders, helping to ensure devices reach patients safely and efficiently. The list mirrors last year’s priorities by again putting air purifying respirators and menstrual products among the top draft documents, items that regulators say remain crucial to public health preparedness and reproductive health oversight.

Several of the planned documents expand on the FDA’s 2022 guidance that set out the agency’s approach to oversight of device software functions and mobile medical applications. That 2022 framework established a risk-based distinction between software that meets the definition of a medical device and lower-risk mobile health tools. The new 2026 priorities indicate the agency will further refine those rules, particularly around artificial intelligence and continuous software updates.

The FDA’s so-called B-list of final guidance priorities includes high-attention items: premarket considerations for weight loss devices, lifecycle management and marketing submission recommendations for AI-enabled software, and the content of human factors information in medical device marketing submissions. Each topic has immediate ties to active areas of development: endoscopic and implantable therapies for obesity are proliferating, AI is being embedded across diagnostics and monitoring tools, and human factors studies are critical to preventing user error.

Regulators and industry experts say guidance documents do not have the force of law but serve as the practical roadmap companies use to design studies, prepare submissions and align postmarket practices. For developers of AI-enabled software, the guidance could spell out expectations for ongoing monitoring, performance updates and transparency around training data—areas that have vexed both entrepreneurs and patient advocates.

The inclusion of menstrual products signals a broader regulatory posture toward commonly used consumer-reproductive health items, an area that has seen renewed attention amid debates about product safety and claims. Separately, the emphasis on respirators responds to lessons from the COVID-19 pandemic about supply resilience and filtration standards.

Manufacturers and trade associations have long urged clearer, more specific guidance to shorten regulatory timelines and reduce the cost of bringing novel devices to market. Clear expectations for human factors documentation and premarket data for weight loss devices, for example, could reduce variability in review outcomes and set consistent safety benchmarks.

Public comment periods typically follow the release of draft guidances, giving clinicians, patient groups and industry a chance to weigh in on proposed expectations. The FDA did not provide exact publication dates for each draft, but the agency indicated it will work through the fiscal year to develop and publish the documents.

As medtech innovation accelerates, the FDA’s annual guidance road map will be watched closely for signals about how regulators plan to balance rapid adoption with safeguarding patients—particularly when software and artificial intelligence become integral to diagnosis, treatment and device operation.