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  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  5. CDRH Proposed Guidance Development
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

CDRH Proposed Guidance Development

Each year, the Center for Devices and Radiological Health (CDRH) identifies the guidance documents (medical devices and radiation-emitting products) to be included in CDRH’s annual guidance agenda for the upcoming fiscal year (October 1 to September 30).

On this page:

Proposed Guidances by Year

Why does CDRH post lists of guidance documents it intends to issue?

In the previous Medical Device User Fee Amendments of 2012 (MDUFA III), 2017 (MDUFA IV) and 2022 (MDUFA V), the FDA agreed to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more efficiently. These include: 

  • Posting annually a list of prioritized device guidance documents CDRH intends to publish each fiscal year (the "A-list").
  • Posting annually a list of device guidance documents CDRH intends to publish as resources permit each fiscal year (the "B-list").
  • Providing the public an opportunity to provide feedback, including draft language for guidance documents.
  • Finalizing, withdrawing, reopening the comment period, or issuing a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods and 100% within 5 years of the close of the comment periods, as resources permit.

Additionally:

  • We encourage the public to submit comments indicating the relative priority of different guidance topics on the A-list and B-list. Comments and suggestions can also be emailed at any time to the CDRH Guidance Program. The comments received will help us prioritize the allocation of resources to specific guidance topics on the lists.

Does CDRH expect to publish all the guidances included on the A-list and B-list?

CDRH strives to publish the guidances on the A-list and B-list, which we identify at the start of our fiscal year. However, our experience has identified several reasons why we may be unable to publish all the guidances prospectively identified on these lists, including:

  • Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or addressing issues of public health importance.
  • CDRH often needs to publish guidance documents that are not known in advance. These may involve newly identified issues of public health importance.

Additionally:

  • We are not required to publish every guidance identified if the resources needed would be to the detriment of meeting quantitative review timelines and statutory obligations.
  • We are not precluded from issuing guidance documents that are not on either list.
  • Guidance topics on this and past guidance priority lists may be removed or modified based on current priorities, as well as comments received regarding these lists.
  • Priorities are subject to change at any time (for example, newly identified safety issues). 

What is the “Under Construction” list of guidances?

Starting in FY 2025, CDRH is providing an additional list - “Under Construction.” This list identifies the guidance documents that CDRH intends to develop as resources permit that are not on the A- or B-list. 

The “Under Construction” list does not represent the totality of guidances CDRH intends to develop, but is intended to promote transparency to interested parties. 

Why does CDRH post a list of guidance documents as part of its retrospective review?

CDRH annually conducts a review of previously issued final guidances in collaboration with interested parties to ensure that final guidance documents continue to provide the public with the Agency's current thinking. Since FY 2015, CDRH has provided a “Retrospective Review” list that identifies previously issued final guidances that are subject to review. 

If during the retrospective review, CDRH determines a guidance document no longer represents the FDA’s interpretation of, or policy on, a regulatory issue, these guidances may be withdrawn and added to the Withdrawn Guidance web page, or revised.

CDRH is interested in receiving external feedback regarding whether the final guidances identified for retrospective review should be revised or withdrawn. CDRH will consider the information received from this retrospective review when determining priorities for updating such guidance documents and will revise these as resources permit.

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