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.

Current guidance documents are available via the guidance document search engine.

What IVD Guidance Documents are available?

You can get a list of all IVD Guidance Documents at the IVD Guidance Documents Webpage.

Where can I get additional information about CDRH Guidance Documents?

You can get additional information about CDRH Guidance Documents from the CDRH Guidance Document Website.