Guidance Documents (Medical Devices and Radiation-Emitting Products)

Guidance documents are prepared for the FDA’s staff, regulated industry, and the public to describe the FDA’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 establish any rights for any person and is not binding on FDA or the public. An alternative approach may be used if it satisfies the requirements of the applicable statue and regulations.

Additional Information

• Search for official FDA guidance documents and other regulatory guidance for all topics
• CDRH Proposed Guidance Development
• CFR Sec. 10.115 Good Guidance Practices
• Radiation-Emitting Products Guidance Documents

Contact FDA

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