FDA’s device center releases guidance agenda for FY 2027
Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug Administration (FDA) Center for Devices and Radiological Health for fiscal year (FY) 2027, the center announced on 1 October. CDRH plans to publish 11 final guidance documents and three draft guidance documents this fiscal year.
The list is divided into three sections. The “A” list contains final guidance documents that CDRH considers a priority, the “B” list covers topics that CDRH plans to publish as resources become available, and an “Under Construction” category identifies additional guidance documents that CDRH intends to develop as resources allow.
CDRH said a top priority is finalizing guidance on lifecycle management recommendations for AI-enabled device software functions. The draft guidance, issued in January 2025, addresses how to apply a total product lifecycle (TPLC) approach to an AI-enabled device, and how to consider issues such as user interface (RELATED: FDA issues draft guidance on developing and managing AI-enabled devices, Regulatory Focus 6 January 2025).
Another top priority is finalizing guidance on PCCPs; a draft was issued in August 2024 (RELATED: FDA issues much-anticipated PCCP draft guidance, Regulatory Focus 22 August 2024). The draft details the modifications the agency says are needed for a PCCP and specifies the information sponsors should include in their premarket approval (PMA), de novo, or 510(k) submissions to support the acceptance of their proposed PCCPs.
Typically, when a manufacturer wants to make changes to a product already on the market, they must submit a supplement or a new application to the FDA outlining those changes for review. However, in certain cases, the agency has agreed to allow companies to implement changes without filing a supplement or new application, provided the changes are pre-approved by the agency.
CDRH said third high-priority topic is finalizing guidance on robotic-assisted devices. The guidance outlines the agency’s thinking on bringing certain robotically assisted surgical devices (RASD) to market and includes non-clinical and clinical testing requirements that sponsors should include in their premarket submissions. A draft guidance was issued in September (RELATED: FDA draft guidance addresses considerations for robotically assisted surgical devices, Regulatory Focus 29 September 2026).
Other top priorities include finalizing a compliance policy for certain NIOSH [National Institute for Occupational Safety and Health] approved air-purifying respirators, performance testing and labeling recommendations for menstrual products, quality management system information for certain premarket application reviews, and an accreditation scheme for its conformity assessment (ASCA) program.
Another top priority is issuing a draft guidance on recommendations for generative AI-enabled conversational devices for mental health disorders.
CDRH has indicated that it is prioritizing the finalization of guidance on user fees for small businesses in the medical device sector. Additionally, the agency plans to conduct non-clinical and clinical performance testing for pulse oximeters and gather feedback on the Q-Submission program. However, these three guideline documents have been categorized on the B list, which means they are considered lower priority.
The agency aims to issue two draft guidance documents, also included on the B list. These documents will focus on policies governing software functions in medical devices and the post-market cybersecurity management of these devices.
CDRH has categorized four documents as low priority, placing them in its third tier. These documents address the following topics: considerations for selecting a predicate device to support a premarket notification, evaluating the thermal effects of medical devices that generate tissue heating or cooling, conducting risk assessments for generative AI-enabled devices, and assessing substantial equivalence in premarket notifications.
CDRH is seeking feedback on its prioritization scheme for the A and B lists and is interested in input on whether other additional guidance is necessary. The deadline for submitting comments is 30 November 2026. Submit comments to docket FDA-2012-N-1021.
The lists were mandated by the Medical Device User Fee Amendments (MDUFA V).
