December 16, 2024

CDRH Looks Ahead With FY 2025 Proposed Guidance Agenda

Marissa Hill Daley, Henry Fisher, Paul Gadiock, Karis Jackson, Jae Hyun Lee, James Ravitz, Michael Ryan, Rachel Stauffer, Jeff Weinstein

McDermott Will & Emery

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Overview

On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY). The proposed guidance documents span a wide range of device topics, including real-world evidence in the device submission process, artificial intelligence (AI)-enabled functionalities in medical devices, and enforcement priorities following the regulation of laboratory developed tests (LDTs). Notably, this agenda was released by the Biden administration. The new administration will revisit the agenda and likely issue an updated version with its own priorities in early 2025.

In Depth

The proposed documents for the agenda are divided into three tiers of descending priority:

The A-list, representing the agency’s top priorities for CDRH.
The notably shorter B-list.
The “Under Construction” list for guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list.

The table below details the most important guidances included on CDRH’s regulatory agenda:

Guidance	Description	Other Resources
Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls	A final guidance document on the A-list that will respond to a 2024 final rule, which in part announced an intent to phase out FDA’s previous general enforcement discretion approach to LDTs.	McDermott has previously tracked FDA’s LDT enforcement policy; see our On the Subject that discusses these policies in greater depth.
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (Revision)	A final guidance document on the A-list that will describe best practices for the Q-Submission Program, which comprises approved, manufacturer-FDA interactions such as pre-submissions, submission issue requests, study risk determinations, informational meetings, and premarket approval day 100 meetings. The guidance will also detail various uncategorized and informal interaction types that may be available to device manufacturers. FDA previously issued draft guidance on March 15, 2024.
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Revision)	A final guidance document on the A-list that will describe FDA’s current position on the use of real-world data (which includes clinically relevant electronic health records data and medical claims data) during the submission process. The document will also discuss the salience of real-world data in the performance of FDA’s regulatory responsibilities. FDA previously issued draft guidance on December 19, 2023.
Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions	A final guidance document on the A-list that will detail FDA’s current thinking on how manufacturers of devices with AI or machine-learning capabilities should structure a premarket control plan when drafting a marketing submission for a device with pre-planned modifications. A draft guidance document published in April 2023 suggested that manufacturers include a description of planned modifications, their modification protocol, and a modification impact assessment. FDA issued this final guidance earlier than anticipated, on December 3, 2024.
AI-Enabled Device Software Functions: Lifecycle Management Considerations and Pre-Market Submission Recommendations	A draft guidance document on the A-list responding to FDA’s recent interest in applying a “lifecycle management framework” to the regulation of AI-enabled medical devices. The Director of FDA’s Digital Health Center of Excellence, Troy Tazbaz, published a blog post on this topic in July 2024. In November 2024, FDA’s Digital Health Advisory Committee engaged in a panel discussion about total lifecycle considerations for technologies leveraging generative AI.
Enforcement Discretion Policy for Certain LDTs for Unmet Needs: Frequently Asked Questions	A draft guidance document on the A-list.
In Vitro Diagnostics: Labeling	A draft guidance document on the A-list that would detail FDA’s expectations and provide recommendations for the labeling of in vitro diagnostic tests. In May 2024, FDA published a final rule that clarified the Federal Food, Drug, and Cosmetic Act’s application to in vitro diagnostic products, including when they are manufactured by a laboratory. FDA held a webinar on complying with labeling requirements for in vitro diagnostic tests in September 2024.
Policy for Regulatory Status of Device Software Functions (Revision)	A draft guidance document on the B-list that would revise a final guidance document published in 2022, titled “Policy for Device Software Functions and Mobile Medical Applications.” The current iteration of this guidance highlights FDA’s intention to focus its oversight on mobile medical apps, defined as devices used as an accessory to regulated medical devices or to transform a mobile platform into a regulated medical device.
Clinical Evidence Considerations for Digital Mental Health Treatment Devices, Including Computerized Behavioral Therapy Devices	A draft guidance document on the Under Construction list.
Best Practices for Selecting a Predicate Device to Support a Premarket Notification (510(k)) Submission	A final guidance document on the Under Construction list that will assist manufacturers in selecting an appropriate predicate device for their 510(k) submission. In a previously published draft guidance document, the four best practices were listed as: Basing a 510(k) submission on a predicate device that has been cleared via well-established methods Selecting a device that has remained safe and effective consistently in its intended use environment Refraining from selecting a device that has known or emerging use- or design-related safety issues Refraining from selecting a device that has been subject to a design-related recall.
Recommendations for the Use of Clinical Data in Premarket Notification (510(k)) Submissions	A final guidance document on the Under Construction list that will clarify when manufacturers may need to provide clinical data to establish that a device is substantially equivalent to a predicate device. In its previously published draft guidance, FDA highlighted four scenarios where such submissions may be appropriate, including those where clinical data would be useful to evaluate differences between the two devices’ indications for use.
3D Printing Medical Devices at the Point of Care	A draft guidance document on the Under Construction list. CDRH released a discussion paper on this topic in 2021, identifying the unique challenges presented by the 3D printing of medical devices in the point of care context and enumerating several principles to be considered when structuring a related regulatory framework. These principles included employing a risk-based approach to regulation, understanding the varying technical capabilities of facilities, and leveraging the least burdensome approach to ensure printed devices are safe and effective.
General/Specific Intended Use (Revision)	A draft guidance document on the Under Construction list that would revise final guidance published in 1998 on the same topic. The current iteration of this guidance details the criteria that FDA uses when determining whether a device meets substantial equivalence requirements for general versus specific uses. Among other criteria, the list includes a specific use’s potential risks, its potential public health impact, and whether there is clinical evidence that supports the specific use.
Substantial Equivalence With Limitations: 510(k) Devices (Revision)	A draft guidance document on the Under Construction list that would revise a final guidance document published in 2002, titled “Determination of Intended Use for 510(k) Devices.” The current iteration of this guidance specifies how FDA determines the intended use of a device for purposes of a substantial equivalence analysis. FDA looks to the proposed labeling of the device as well as the likelihood that the device could be used for a harmful purpose beyond its proposed label.

CDRH also anticipates that certain regulations impacting medical devices may be finalized in 2025:

A proposed rule that would create procedures for placing a clinical hold and suspending a clinical investigation of a medical device.
A proposed rule to classify minimally manipulated allograft hearth valves as Class III devices.
A final rule to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices into Class II with special controls.
A final rule and companion proposed rule that would amend 21 C.F.R. part 807 to correct inconsistencies related to registration and listing requirements for human cells, tissues, or cellular or tissue-based products regulated as devices and would require that they follow 21 C.F.R. part 807 registration and listing procedures.

In addition to inviting general comments on the substantive topic areas covered by each of the proposed guidance documents, CDRH requests stakeholder comments on how the guidance documents should be prioritized internally.

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