The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) published proposed guidance lists for fiscal year 2027, providing companies, researchers, and interested parties with an opportunity to influence the priorities for regulatory documents that will be issued or developed during the upcoming period.
Three Levels of Priority
The plan divides the guidance into three lists. List A includes priority documents that the center intends to publish during fiscal year 2027. List B includes documents that it intends to publish if available resources permit. The “Under Construction” list includes guidance that the center intends to develop when resources become available but that does not appear on Lists A or B.
Inclusion of a document on these lists does not guarantee that it will be issued by a specific date; the center describes them as proposed plans linked to priority and resources. A PDF file provided details of Lists A and B and the documents under development.
Deadline and Participation Process
CDRH is accepting comments on the lists or on a specific guidance document through November 30, 2026, via Regulations.gov. Comments will be available to the public, except for submissions identified as “Confidential Submissions.” The public notice file can also be accessed under docket FDA-2012-N-1021.
The center is requesting views on the relative ranking of the priorities for documents on Lists A and B, as well as on the policies or information that should be included in the guidance. It also welcomes proposals for new topics or requests to withdraw or revise existing guidance, provided that the reasons for the proposed change and how it would be implemented, where applicable, are explained.
What Matters to Medical Device Stakeholders?
This process gives companies and professional organizations an opportunity to influence the interpretive framework that FDA will use for medical device and radiation-emitting product submissions. Its practical value lies in the fact that comments are not limited to expressing an opinion on a completed document; they can also address the ranking of priorities and propose new guidance or revisions to existing documents.
However, the plan remains an indicator of the direction of regulatory work rather than a binding implementation schedule. Stakeholders therefore need to distinguish between what appears on the priority lists and what will actually be published, particularly because Lists A and B are linked to the center’s ability to provide resources.
Previous Implementation Indicators
CDRH reported that during fiscal year 2026 it published seven of the 11 guidance documents listed on Lists A and B, including five from List A and two from List B.
The center also commits, to the extent resources permit, to taking action on 80% of draft guidance documents within three years after the close of the comment period and on 100% of them within five years. The data show that the percentage of actions within three years ranged from 79% to 100% for the fiscal year 2016 through 2022 cohorts, while the percentage within five years ranged from 86% to 100%. Nevertheless, in fiscal year 2026, two drafts issued before October 1, 2020, remained without final action, according to the article.