U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  1. Device Advice: Comprehensive Regulatory Assistance

Guidance Documents (Medical Devices and Radiation-Emitting Products)

Search for FDA Guidance Documents

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.

Additional Information

Standard Operating Procedures

Contact FDA

1 (800) 638-2041
(301) 796-7100

Information-Medical Devices / Radiation Products
Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Summary Document Issue Date FDA Organization regulated product taxonomy hidden Topic old hidden Topic Guidance Status Open for Comment Comment Closing Date on Draft Docket Number Guidance Type hidden center taxonomy hidden
Back to Top