CDRH Proposed Guidance Development
Each year, the Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents that it intends to publish during the fiscal year. These lists are:
- The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year.
- The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal year.
CDRH also posts an annual retrospective list of previously-issued guidances for stakeholder review and input.
On this page:
- Proposed Guidances by Year
- Why does CDRH post lists of guidance documents it intends to issue?
- Does CDRH expect to complete the A-list and B-list?
- Why does CDRH post a list of guidance documents as part of its retrospective review?
Proposed Guidances by Year
- CDRH Proposed Guidances for Fiscal Year 2023 (FY2023)
- CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) [ARCHIVED]
Why does CDRH post lists of guidance documents it intends to issue?
During negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III) and the Medical Device User Fee Amendments of 2017 (MDUFA IV), 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. Among other things, the FDA agreed to:
- Post annually a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (FY) (the "A-list").
- Post annually a list of device guidance documents that the Agency intends to publish as resources permit each fiscal year (the "B-list").
- Provide stakeholders an opportunity to provide feedback, including draft language for guidance documents.
- Finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods and 100% within 5 years of the close of the comment periods, as resources permit.
Does CDRH expect to complete the A-list and B-list?
CDRH strives to complete the list of guidances which we identify at the start of our fiscal year. However, our experience has identified a number of reasons why we may be unable to publish all of the guidances prospectively identified, 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 issue a number of guidance documents that are not known in advance. These may involve newly identified issues of public health importance.
Accordingly, CDRH encourages stakeholders to submit comments indicating the relative priority of different guidance topics. In addition, CDRH considers stakeholder feedback to the docket to help prioritize the allocation of resources to specific guidance topics on the lists.
Why does CDRH post a list of guidance documents as part of its retrospective review?
To ensure that final guidance documents continue to provide stakeholders with the Agency's current thinking, CDRH annually conducts a staged review of previously issued final guidances in collaboration with stakeholders. Since FY 2015, CDRH has provided lists of previously issued final guidances that are subject to review annually on the FDA.gov website. CDRH intends to continue to provide lists of previously issued final guidances that are subject to review each year. For instance, in FY 2022, CDRH has provided a list of the final guidance documents that issued in 2012, 2002, 1992, and 1982; in FY 2023 CDRH is providing a list of the final guidance documents that issued in 2013, 2003, 1993, and 1983, and so on.
When CDRH withdraws a guidance document that no longer represent the Agency's interpretation of, or policy on, a regulatory issue, these guidances are listed on the Withdrawn Guidance web page.
CDRH is interested in receiving external feedback regarding whether these final guidances 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.