Medical Devices

Guidance Documents - About Guidance

What is 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:

Abbreviation Office Name
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

 

Page Last Updated: 12/16/2014
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