Medical Devices

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.

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

Page Last Updated: 03/27/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English