Guidance Documents - About Guidance
Good Guidance Practice (GGP) documents are documents prepared for CDRH staff, regulated industry and the public that relate to:
- the processing, content, and evaluation of regulatory submissions
- the design, production, manufacturing, and testing of regulated products
- the inspection and enforcement procedures
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.
Most guidance documents exist on the Web and are available via the CDRH Guidance Document page.
|The following table contains the abbreviations used for Office names: |