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U.S. Department of Health and Human Services

Medical Devices

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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:


Office of Compliance
Office of the Center Director
Office of Device Evaluation
Office of Communication, Education, and Radiation Programs
Office of Management Operations
Office of Surveillance and Biometrics
Office of Science and Engineering Laboratories
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