FDA guidance documents explain the agency’s interpretation of, or policy on, a regulatory issue. The FDA prepares guidance documents for regulated industry, its own staff, and the public. FDA uses guidance documents to explain the Agency’s current thinking on such matters as the design, manufacturing, and testing of regulated products; scientific issues; content and evaluation of applications for product approvals; and inspection and enforcement policies.
Although guidance documents are not legally binding, they provide insight to approaches that may help regulated industry reach their regulatory goals. Other approaches that satisfy the relevant law and regulations may be used. FDA periodically reassesses its guidance practices and makes improvements, as appropriate, to ensure that FDA is using current best practices with regard to the prioritization, development, issuance, and use of its guidance documents.
Guidance Development
FDA issues a substantial number of guidance documents each year. For instance, in fiscal year (FY) 2023, FDA issued more than 190 guidance documents, either as draft or final. In FY 2022, we issued roughly the same number. Between 2011 and 2019, FDA annually published between 112 and 231 guidance documents, for an average of 173 annually. These totals reflect only Level 1 guidance documents and Level 2 guidance documents with an accompanying NOA.
Level 1 guidance documents set forth the agency’s initial interpretations of statutory or regulatory requirements; describe changes in FDA’s earlier interpretation or policy that are of more than a minor nature; and deal with complex scientific or highly controversial issues.
In addition, FDA issues Level 2 guidance documents, which address existing practices or minor changes in FDA’s interpretation or policy.
Industry, consumers, and others play a significant role in the agency’s guidance development processes. FDA welcomes suggestions of topics for guidance documents and proposed draft guidance documents may be submitted to FDA. Submitting proposed draft guidance documents, rather than guidance topics, may enable FDA to approach a guidance topic with a better understanding of the issues of interest.
The agency also invites the public to comment on its draft Level 1 guidance documents and reviews and considers the submitted comments in preparing the final documents. In some instances, FDA may hold public meetings or workshops on published draft Level 1 guidance documents to solicit additional feedback, or present them to an advisory committee for review.
Although Level 2 guidance documents and Level 1 guidance documents “for immediate implementation” are implemented without prior public comment, all FDA guidance documents are posted on the agency’s Website, and anyone can submit comments on any FDA guidance documents anytime. FDA reviews all comments and revises its guidance documents, as appropriate.
Guidance Best Practices
As part of the Transparency Initiative, a cross-Agency working group was convened to identify FDA’s “best practices” for making the agency’s guidance development processes more transparent and efficient.
In 2011, the working group, under the leadership of the Office of Policy in the Office of the Commissioner, prepared a report, entitled the Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency (GGP Report).
Since 2011, FDA has made significant strides to modernize and enhance our best practices for the efficient initiation, prioritization, development, review, clearance, and issuance of guidance documents. FDA has prepared a draft document entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance.” This draft report responds to section 2505(a) of the Consolidated Appropriations Act (Public Law 117-328) of 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices.
Click to download: Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance [ PDF - 1.17 MB]
Click to download: Federal Register Notice Announcing availability of the Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance [ PDF TBD]
