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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:

Offices

OC
 Office of Compliance
OCD
 Office of the Center Director
ODE
 Office of Device Evaluation
OCER
 Office of Communication, Education, and Radiation Programs
OMO
 Office of Management Operations
OSB
 Office of Surveillance and Biometrics
OSEL
 Office of Science and Engineering Laboratories
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