FDA Device Guidance Agenda: What to Watch in 2026

FDA’s Center for Device and Radiological Health (CDRH) posted its updated guidance agenda for Fiscal Year 2026, including an “A” list prioritizing the release of four final and four draft guidance documents this upcoming year. In addition, CDRH’s “B” list – which FDA explains are guidance documents that CDRH intends to publish in FY-2026 “as resources permit” – pledges finalization of three guidance documents (with no draft guidance documents indicated on the “B” list). We are closely monitoring for the publication of the following guidances that FDA has placed on its “A" list:

• “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” The draft version of this guidance was published in December 2023, since which time FDA’s drug center has released several real-world evidence (RWE) guidance documents. Meanwhile, the device industry has been eagerly awaiting the finalization of CDRH’s RWE. In discussing the lack of harmonization of RWE guidances between the centers with FDA officials, we understand that it may be due to fundamental differences in regulatory standards for drugs and medical devices, although the RWE concepts are similar.
• “Predetermined Change Control Plans for Medical Devices.” In December 2024, FDA issued final guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial intelligence-enabled device software function (AI-DSF), as we analyzed at the time online here. A PCCP is critical to enable a device sponsor to obtain FDA pre-approval for intended modifications (and their method of implementation) to an AI-DSF without the need for additional marketing submissions for each modification delineated and implemented in accordance with the PCCP. This guidance – along with other AI-related guidance documents previewed below – are at the heart of regulatory innovation for adaptive technologies, and we anticipate hearing how FDA aims to balance flexibility with safety as medical devices become more autonomous and self-updating.
• “Policy for Device Software Functions.” In September 2022, FDA finalized the guidance entitled, “Policy for Device Software Functions and Mobile Medical Applications,” making minor updates to the 2019 guidance of the same name, which clarifies FDA’s thinking on the regulation of applications meant to run on a mobile platform or on a browser tailored for use on a mobile platform. We will be closely monitoring for changes that CDRH will make to its guidance in this rapidly evolving AI software arena.
• “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle” (TPLC). The draft version of this guidance was published in September 2024, but the current final version of the guidance – from August 2016 – only applies to marketing submissions in the premarket period. It will be interesting to see what FDA intends to clarify regarding patient preference information (PPI) in the postmarket setting, including whether PPI will be used in postmarket surveillance, recalls, or device modifications, potentially leading to more patient-driven regulatory actions.
• “Quality Management System Information for Certain Premarket Submission Reviews.” FDA said it will release new draft guidance on this topic, although it is presently unclear what may be updated from the existing 22-year-old final guidance. In February 2024, however, FDA had published a long-awaited final rule entitled, “Medical Devices; Quality System Regulation Amendments,” which amended the device current good manufacturing practice (GMP) requirements of the Quality System Regulations (QSR), primarily to align the U.S. regulations more closely with the International Organization for Standardization (ISO) standard 13485:2016 – which is the international consensus standard for medical devices – by converging most of the QMS requirements used by FDA and regulatory authorities from other countries; we analyzed that FDA rule online here. The rule – commonly referred to as the Quality Management System Regulation (QMSR) – represents a major step toward global harmonization of device regulatory requirements. The QMSR is set to go into effect on February 2, 2026, and FDA still needs to make many adjustments to accommodate the new standard. In the forthcoming QMS guidance, we expect FDA may clarify the types of QMSR documentation that device manufacturers must include in premarket submissions – covering design controls, manufacturing processes, and readiness for inspection – to support streamlined, globally aligned device reviews, helping manufacturers navigate both U.S. and international regulatory landscapes with greater efficiency.

The “B” List

FDA’s “B” list for FY-2026 includes the following three entries:

• “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Marketing Submission Recommendations.” The draft version of this guidance was published in January 2024, as we analyzed at the time online here. It consolidated the recommendations that FDA has been providing over the years on the content needed in a marketing application pertaining to a device with AI-enabled software functions in order to facilitate FDA’s determination as to the safety and effectiveness of the device for purposes of granting a marketing authorization.
   
  In the artificial intelligence arena, FDA has also announced that on November 6, it will hold its second digital health advisory committee meeting, this time focusing on Generative AI in mental health. In addition, FDA has issued a Request for Public Comment on the evaluation of devices that integrate artificial intelligence; we have a new analysis of the agency’s concerns expressed in that announcement online here.

Together, these initiatives reflect FDA’s commitment to building a robust, forward-looking regulatory ecosystem for AI in healthcare—one that fosters innovation while safeguarding public health. These developments could impact submission strategy, post-market obligations, and cross-functional collaboration between regulatory, data science, and clinical teams.

• “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” The draft version of this guidance was published in September 2023. Due to the widespread production of GLP-1 medications to treat weight loss, it is possible FDA may be making adjustments to its outlined risk-benefit framework for corresponding medical devices.
• “Content of Human Factors Information in Medical Device Marketing Submissions.” The draft version of this guidance was published in December 2022, and we expect an FDA update could reflect new expectations for usability, especially as devices become more complex by way of robotics and AI. We anticipate discovering in this guidance whether FDA may raise the bar for user interface design and risk mitigation.

“Under Construction”

FDA also indicated that it has nine new guidance documents “under construction,” which means CDRH intends to develop them “as resources permit”; most notably, those include the following:

• “Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices.” The construction of this guidance is timely, given the boom-and-bust cycle in digital therapeutics. We speculate FDA may incorporate lessons learned from recent failures and successes, and clarify evidence standards for behavioral health.
• 510(k) guidance. FDA lists several 510(k) guidance documents as under construction, including “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission,” “Evidentiary Expectations for 510(k) Implant Devices,” “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions,” and “Substantial Equivalence with Limitations: 510(k) Devices.” These guidances were released in draft form in September 2023, as we described online here, suggesting the new documents will be final guidance. It remains to be seen how the final guidances will differ from the draft guidances.
• “Robotically-Assisted Surgical Devices.” In 2021, FDA issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. We will be monitoring for this new RAS guidance to see if the agency continues to ratchet up the requirements for computer-assisted surgical systems.

Next steps

This guidance agenda is noticeably shorter than those published in prior years, perhaps signaling CDRH’s need to prioritize high impact topics due to resource constraints, especially as FDA faces increasing demands in digital health, AI, and post-pandemic oversight. This may reflect a more focused regulatory strategy, or merely the agency’s limited bandwidth.

At the same time, we are observing FDA’s inspection strategy becoming more targeted, data-driven, and unforgiving of systemic compliance gaps. Online here we predict key CDRH compliance trends, comparing them to historic FDA behavior, and recommend ways for device manufacturers to stay ahead of the curve.

FDA has invited stakeholders to submit comments indicating the relative priority of different guidance topics on its “A” and “B” lists. If you may wish to submit a comment, or have questions regarding any of the topics outlined above, please do not hesitate to reach out to either of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Jodi Scott and Kristin Zielinski Duggan