Dive Brief:
- The Food and Drug Administration released a list of the medical device guidance documents it plans to work on in its 2025 financial year, with topics like laboratory developed tests, artificial intelligence and cybersecurity filling out the agenda.
- The list, which the FDA published last week, shows that the Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs.
- Other priorities include the finalization of documents on cybersecurity in premarket submissions and predetermined change control plans (PCCPs) for AI, plus the drafting of guidance on AI lifecycle management.
Dive Insight:
Guidance titled “Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls” is a notable new addition to the FDA’s list of priorities. While many of the priorities for 2025 were part of the FDA’s plans in 2024, the final LDT guidance is wholly new.
This year, the FDA plans to work to finalize one LDT text and draft a second document. The second text will answer frequently asked questions about the enforcement discretion policy for LDTs that address unmet needs.
LDT regulation has become an increasingly contentious issue between labs and the FDA. The agency published a final rule in April that strengthened its oversight of LDTs, triggering pushback from the lab industry and Congress. A House committee told the FDA to suspend the rule, and groups representing the lab and pathology sectors sued the agency to block the changes.
The FDA’s other guidance priorities for 2025 have carried over from 2024. Last year, the agency listed “Select Updates for Premarket Cybersecurity Guidance” among its draft guidance priorities. This year, the administration is aiming to finalize cybersecurity guidance on quality system considerations and the content of premarket submissions.
Meanwhile, two AI documents are still at the same stage as last year. Like in 2024, the FDA is planning to spend 2025 drafting guidance on lifecycle management considerations and premarket submission recommendations for AI-enabled device software functions. Another document on PCCPs for AI-enabled devices is still at the finalization stage.
The PCCP document was one of three final guidance documents the FDA prioritized in 2024. The FDA has only finalized one of the documents, publishing guidance on the remanufacturing of medical devices in May. The third document on the 2024 list, which is focused on device shortages, is one of the FDA’s final guidance priorities for 2025.
The FDA released draft guidance on PCCP in August and requested public comment. In the draft, the agency outlined how a PCCP might work in the context of medical devices that use AI or machine learning.
Having focused on draft documents in 2024, the FDA is aiming to finalize more guidance texts in 2025. The 2024 list of top priorities included three final guidance documents and 18 drafts. This time, the FDA has included 11 final documents and seven drafts.
The list of drafts includes the revision of guidance on menstrual tampons, which the FDA began investigating in September in response to toxicity concerns.
