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.
|OC||Office of Compliance|
|OCD||Office of the Center Director|
|OCE||Office of Communication and Education|
|ODE||Office of Device Evaluation|
|OIR||Office of In Vitro Diagnostics and Radiological Health|
|OMO||Office of Management Operations|
|OSB||Office of Surveillance and Biometrics|
|OSEL||Office of Science and Engineering Laboratories|