Medical Devices

Guidance Documents (Medical Devices and Radiation-Emitting Products)

What is guidance?

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:

  • the design, production, labeling, promotion, manufacturing, and testing of regulated products
  • the processing, content, and evaluation or approval of submissions
  • inspection and enforcement policies

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.

Page Last Updated: 01/22/2015
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