Rules & Guidance for Industry

Rules and Guidance for Industry related to the FDA Food Safety Modernization Act (FSMA).

For additional information on the rulemaking process, see The Food Safety Law and the Rulemaking Process: Putting FSMA to Work.

View tutorials are also available:

• FDA Food Safety Modernization Act: A Primer by FDA 

• The Rulemaking Process: A Primer by FDA  

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• What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
  Guidance for Industry
  Docket Number: FDA-2011-D-0643
  March 2013

• Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
  Final Rule
  Docket Number: FDA-2011-N-0197 
  February 2013

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food 
  Proposed Rule
  Docket Number: FDA-2011-N-0920
  January 2013

• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  
  Proposed Rule
  Docket Number: FDA-2011-N-0921
  January 2013

• What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide  
  Guidance for Industry
  Docket Number: FDA-2012-D-1003
  December 2012 

• Questions and Answers Regarding Food Facility Registration (Fifth Edition)
  Guidance for Industry
  Docket Number: FDA-2012-D-1002
  December 2012 

• Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories
  Guidance for Industry
  Docket Number: FDA-2012-D-0585
  October 2012

• Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements 
  Interim Final Rule 
  Docket Number: FDA-2002-N-0153
  February 2012 

• FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
  Draft Guidance for Industry
  Docket Number: FDA-2011-D-0674 
  February 2012 

• Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) 
  Guidance for Industry
  Docket Number: FDA-2011-D-0598
  February 2012 

• Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
  Guidance for Industry
  Docket Number: FDA-2011-D-0721
  September 2011

• Enforcement Policy Concerning Certain Prior Notice Requirements
  Guidance for Industry
  June 2011

• Draft Guidance: New Dietary Ingredient Notifications and Related Issues
  Draft Guidance for Industry
  Docket Number: FDA-2011-D-0376

• Information Required in Prior Notice of Imported Food 
  Interim Final Rule
  Docket Number: FDA-2011-N-0179 

• Fish and Fishery Products Hazards and Controls Guidance
  Guidance for Industry
  Docket Number: FDA- 2011-D-0287