FDA Wrapped: Prominent Guidance From 2024FDA Wrapped: Prominent Guidance From 2024

The FDA Center for Devices and Radiological Health (CDRH) maintained a brisk pace after a record-breaking 2023. Among other activities — most notably, granting marketing authorization to novel devices — the agency kept the industry informed by way of dozens of guidance documents on everything from artificial intelligence to dental devices.

All that activity comes in a year of transitioning leadership within the department and the agency at large. In October, ophthalmologist Michelle Tarver, MD, PhD, officially assumed the lead role at CDRH after Jeff Shuren retired. In January, pending Senate confirmation, surgeon Marty Makary, MD, will lead the FDA.  

It’s too soon to say how Tarver’s leadership will shape the CDRH, but it’s a safe bet her patients-first approach will have an impact. As deputy director of transformation, Tarver helped launch the FDA’s Home as a Healthcare Hub, which considers people’s living environments in device and clinical trial design. She also takes the helm at a time when CDRH is tasked with evaluating AI- and machine learning-enabled medical devices and re-imagining its framework to do so.

AI remains a priority

Speaking of AI, the agency issued notable guidance this year that applies to AI-enabled medical devices. Its request for Predetermined Change Control Plans (PCCPs) presents a framework for reviewing these devices, enabling developers to update the devices without needing to submit a 510(k) for a software change. The final guidance, issued in early December, outlines the components of a PCCP as well as instructions on PCCP version control and maintenance.

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In August, the agency issued PCCP guidance that applies to all medical devices, not just those with AI. The guidance expands on section 515C(a)-(c) of the Food and Drug Omnibus Reform Act of 2022 (FDORA). Under FDORA, the FDA has explicit authority to authorize PCCPs for all medical devices regardless of regulatory pathway or device type.

AI wasn’t the only focus area for CDRH this year, nor was it the most contentious. Here are a few of the most notable documents produced by CDRH in 2024.

Up in the air: Laboratory-developed test rule 

In May, CDRH issued a final rule stating that in-vitro diagnostics are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when the manufacturer is a lab. The FDA will phase out its less-restrictive enforcement policy over the next four years. The first milestone takes place May 6, 2025. At that time, certain IVD developers will have to comply to medical device reporting requirements, correction and removal reporting requirements, and quality system requirements.

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That’s if pending lawsuits don’t lead to a change to this final rule. The American Clinical Laboratory Association and the Association for Molecular Pathology with pathologist Michael Laposata, both filed suits alleging the FDA exceeded its authority to issue the final rule.

“The final rule certainly caused a lot of discussion among industry, particularly among small and mid-sized labs,” said Megan Robertson, senior counsel for Epstein Becker Green, who focuses her practice on the clinical laboratory and medical device industries. “Labs of all sizes and specialties have been watching and waiting to see what happens, both from the two lawsuits, as well as letters from American Society for Clinical Pathology (ASCP) and College of American Pathologists requesting the incoming Trump administration rescind the rule.”

eSTAR

Use of eSTAR became mandatory for 510(k) submissions to FDA on October 1, 2023. After a period of voluntary use, eSTAR will become mandatory for PMAs and De Novo submissions in October 2025.   

The interactive PDF is intended to make regulatory submission easier and faster and to lessen the possibility of an incomplete submission. Early reports mention difficulties due to an inability to track changes or collaborate on the template in cloud-based platforms. Future iterations may address these issues.

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EtO sterilization facility transition

In April, the Environmental Protection Agency published a final rule to amend its emission standards and established new standards for previously unregulated EtO emissions. As companies make changes to comply with this final rule, they may need to either reduce sterilization activity or move sterilization operations.

To assist with the transition, the FDA issued a guidance document that lays out an enforcement discretion policy to respond to anticipated EtO sterilization activities. The intent is to give sterilization facilities the necessary time to make changes while lessening supply chain disruption.

Clinical trial diversity plan

The latest FDA initiative to improve clinical trial representation comes in the form of its proposed Diversity Action Plan requirement. The guidance document on the plans helps sponsors understand how to comply with the Food and Drug Omnibus Reform Act (FDORA) of 2022, which mandates that the FDA require diversity action plans for certain pivotal device trials. Prior to FDORA, these plans were voluntary. Plans must include enrollment goals, rationale for those goals, and an explanation on how the sponsor plans to meet those goals. Final guidance is forthcoming.

This is only a snapshot of the 44 final and draft guidance documents the came from CDRH this year. While AI and LDTs got the most attention, the agency’s output reflects the breadth of its authority.

Looking ahead, expect more discussion related to advanced technology, and perhaps fewer boundaries around diagnostics —pending the outcome of the LDT rule.

“We’re looking at 2025 as possibly an improving environment for device innovation,” Robertson told MD+DI. “There could be an opportunity for the administration under president-elect Trump to roll back some of the more controversial FDA actions and allow for more flexibility.”