The FDA publishes Guidance Documents, following 21 CFR §10.115, to provide information for stakeholders.
- Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agencys 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; and inspection and enforcement policies.
- Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.
CDRH staff, regulated industry, and the public prepare Guidance Documents related to:
- the processing, content, and evaluation of regulatory submissions
- the design, production, manufacturing, and testing of regulated products
- the inspection and enforcement procedures
FDA published a comprehensive list, organized by Center, in the Federal Register on August 9, 2010.
For devices, you can search CDRH guidance documents at