Guidances

Guidance documents represent FDA's current thinking on a topic.  They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. 

How to Provide Input for Guidance Development 

Interested parties have a number of opportunities to provide input into guidance development.  For more information please see Opportunities for Input Into Guidance Development.(PDF) 21 KB
Interested parties also have a number of opportunities to comment on agency rulemaking.  For more information please see How to Comment on Proposed Regulations and Submit Petitions.

Possible Topics for Future Guidance Development

• Devices
  • Documents the Center for Devices and Radiological Health is Considering for Devlopment (FY11)
• Drugs
  • Guidance Agenda: New Draft Guidances CDER is Planning to Publish During Calendar Year 2011 (PDF - 55KB)
• Radiation-Emitting Products
  • Documents the Center for Devices and Radiological Health is Considering for Devlopment (FY11)
• Vaccines, Blood & Biologics
  
  • Draft Guidances CBER is Planning to Publish During Calendar Year 2012 (PDF - 17KB)

Guidance Documents By Product Area

• All FDA Guidances
• Combination Products
• Animal and Veterinary
  • Recent Animal and Veterinary Guidances
• Color Additives
• Cosmetics
• Drugs
  • Recent Drugs Guidances
• Food
  • Recent Food Guidances
• Medical Devices
  • Recent Medical Devices Guidances
• Radiation-Emitting Products
  • Recent Radiation-Emitting Guidances
• Tobacco Products
  • Recent Tobacco Guidances
• Vaccines, Blood, Biologics 
  • Recent Vaccines, Blood, Biologics Guidances

Guidance Documents By Topic

• General and Cross-Cutting Topics
• Advisory Committee
• Clinical Trials
• Import and Export
• International Conference on Harmonization (ICH)
• Veterinary International Conference on Harmonization (VICH)

Withdrawn Guidance Documents

• Animal and Veterinary
  • Withdrawn/Replaced Guidances
• Drugs
  • New/Revised/Withdrawn List for 2010 (PDF - 105KB)
  • New/Revised/Withdrawn List for 2009 (PDF - 130KB)