CDRH’s FY 2027 Proposed Guidances: Shorter Lists, Focused on Software and AI

FDA’s fiscal year (FY) 2027 began on October 1, 2026, at which time the Center for Devices and Radiological Health (CDRH) released its lists of proposed guidance documents it intends to publish or develop during the fiscal year, including:

• The A-list, which identifies guidance documents CDRH intends to publish.
• The B-list, which identifies the guidance documents CDRH intends to publish as resources permit.
• “Under Construction” list, which identifies guidance documents that CDRH intends to develop as resources permit.

FDA includes 17 guidance documents across all three lists for FY 2027, continuing a downward trend in the number of guidance documents included on the annual lists (29 guidance documents in FY 2025 and 20 in FY 2026). Unsurprisingly, this decrease in the number of planned guidance documents coincides with a reduction in the number of guidance documents that CDRH has actually issued in recent years (as we previously blogged about here). Thus far in 2026, CDRH has issued around 20 guidance documents, compared to its average rate of about 40 guidance documents per year observed between 2022 and 2024.

Across the three lists, a major theme is software, artificial intelligence, and cybersecurity, including:

• Marketing Submission and Lifecycle Management Recommendations for Artificial Intelligence-Enabled Device Software Functions (Final)
• Generative Artificial Intelligence-Enabled Conversational Devices for Mental Disorders: Evidentiary Recommendations (Draft)
  • FDA recently issued a discussion paper (which we blogged on here) posing 26 questions to solicit feedback on the regulation of GenAI.
• Policy for Device Software Functions (retitled from “Policy for Device Software Functions and Mobile Medical Applications”) (Draft)
  • Companies frequently rely on the current version of this guidance in regulatory analyses of non-device software or software subject to enforcement discretion; depending on the nature of the revisions, the impact on industry could be significant
• Postmarket Management of Cybersecurity in Medical Devices (Draft)
• Risk Assessment and Evidentiary Considerations for Generative Artificial Intelligence-Enabled Devices (Under Construction)

The heavy representation of these topics reflects the rapid development of the associated technologies, the growing number of such products in development and on the market, and FDA’s effort to keep its guidance current.

Proposed guidance that cuts across device types:

• Predetermined Change Control Plans for Medical Devices (Final)
• Quality Management System Information for Certain Premarket Application Reviews (Final)
• The Accreditation Scheme for Conformity Assessment (ASCA) Program (Final)
  • As we blogged about previously (here), FDA has raised data integrity concerns about certain testing laboratories and encouraged device developers to partner with ASCA-accredited labs to avoid these issues
• Medical Device User Fee Small Business Qualification and Determination (Final)
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (Final)
• Considerations for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission (Under Construction)
• Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (Under Construction)
• Select Updates for the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Under Construction)

The lists also include plans to finalize several device-specific guidance documents whose drafts were released in the last two years:

• Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators (Final)
• Menstrual Products: Performance Testing & Labeling Recommendations (Final)
• Robotically-Assisted Surgical Devices – Premarket Submissions (Final)
• Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (Final)
  • Interestingly, the pulse oximeter guidance, the oldest of these drafts (January 2025), is the only one on the B-list; the others are all on the A-list

FDA is accepting comments on the proposed guidance lists through November 30, 2026.  We will continue to monitor CDRH’s progress and report on key guidance as it issues.