Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:
- the design, production, labeling, promotion, manufacturing, and testing of regulated products
- the processing, content, and evaluation or approval of submissions
- inspection and enforcement policies
Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.
- Search for official FDA guidance documents and other regulatory guidance for all topics
CDRH Fiscal Year 2017 (FY 2017) Proposed Guidance Development and Focused Retrospective Review of Final Guidance CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance CDRH Fiscal Year 2015 (FY 2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance[ARCHIVED] Recent Final Medical Device Guidance Documents Recent Draft Medical Device Guidance Documents Blue Book Memos - ODE Guidance Memoranda
- CFR Sec. 10.115 Good Guidance Practices