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  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) 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?

During negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-144) and The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA Reauthorization Act of 2017 (Public Law 115-52), the FDA agreed, in return for additional funding from industry, 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").
  • Update the FDA.gov website in a timely manner to reflect the Agency's review of previously published guidance documents, including the withdrawal of guidance documents that no longer represent the Agency's interpretation of, or policy on, a regulatory issue.
  • 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  • Finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods and 100% within 5 years of the close of the comment periods, as resources permit.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 completely 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. CDRH intends to annually provide lists of previously issued final guidances that are subject to review. For instance, in the annual notice for FY 2021, CDRH has provided a list of the final guidance documents that issued in 2011, 2001, 1991, and 1981; the annual notice for FY 2022 is expected to provide a list of the final guidance documents that issued in in 2012, 2002, 1992, and 1982, and so on.

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.

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