Rules and Guidance for Industry related to the FDA Food Safety Modernization Act (FSMA).
| Title | Issued Date |
|---|---|
| Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Revised Introduction and Appendix 1 Docket Number: FDA-2016-D-2343 | 2024/01 |
| Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption Docket Number: FDA-2017-D-0175 | 2023/09 |
| Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 11: Food Allergen Program & Chapter 16: Acidified Foods Docket Number: FDA-2016-D-2343 | 2023/09 |
| Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19 Docket Number: FDA-2020-D-1108 | 2023/07 |
| Guidance for Industry: Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 Docket Number: FDA-2020-D-1304 | 2023/07 |
| Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide Docket Number: FDA-2023-D-1336 | 2023/05 |
| Guidance for Industry: Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Docket Number: FDA-2023-D-1031 | 2023/04 |
| Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Docket Number: FDA-2017-D-5225 | 2023/01 |
| Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government Docket Number: FDA-2017-D-6528 | 2022/10 |
| Guidance for Industry: Laboratory Accreditation for Analyses of Foods - What You Need to Know; Small Entity Compliance Guide Docket Number: FDA-2022-D-1126 | 2022/10 |
| Guidance for Industry: CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Docket Number: FDA-2018-D-0388 | 2022/07 |
| Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting Docket Number: FDA-2019-D-4534 | 2022/05 |
| Draft Guidance for Industry: The Accredited Third-Party Certification Program: Questions and Answers Docket Number: FDA-2022-D-0370 | 2022/04 |
| Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation Docket Number: FDA-2011-N-0143 | 2022/04 |
| Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Docket Number: FDA-2021-D-0563 | 2022/03 |
| Guidance for Industry: FDA's Voluntary Qualified Importer Program Docket Number: FDA-2011-N-0144 | 2022/03 (revised) |
| Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards Docket Number: FDA-2011-N-0146 | 2022/02 (revised) |
| Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act Docket Number: FDA-2017-D-3716 | 2021/12 |
| Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act Docket Number: FDA-2017-D-3716 | 2021/12 |
| Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act Docket Number: FDA-2017-D-3716 | 2021/12 |
| Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period | 2021/03 |
| Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration | 2020/10 |
| Guidance for Industry: Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - - No longer in effect Docket Number: FDA-2020-D-1386 | 2020/05 |
| Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration Docket Number: FDA-2018-D-1398 | 2020/02 |
| Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 14: Recall Plan Docket Number: FDA-2016-D-2343 | 2019/10 |
| Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 Docket Number: FDA-2018-D-0671 | 2019/06 |
| Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Docket Number: FDA-2019-D-2131 | 2019/06 |
| Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds Docket Number: FDA-2019-D-1266 | 2019/03 |
| Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration Docket Number: FDA-2018-D-1398 | 2019/03 |
| Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls Docket Number: FDA-2015-D-0138 | 2018/11 |
| Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Docket Number: FDA-2018-D-3631 | 2018/10 |
| Guidance for Industry: Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AND Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Docket Number: FDA-2016-D-1164 | 2018/09 |
| Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) Docket Number: FDA-2012-D-1002 | 2018/08 |
| Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration Docket Number: FDA-2012-D-1002 | 2018/08 |
| Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration Docket Number: FDA-2018-D-1398 | 2018/06 |
| Guidance for Industry: #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program Docket Number: FDA-2018-D-1861 | 2018/06 |
| Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide Docket Number: FDA-2018-D-1468 | 2018/05 |
| Guidance for Industry: The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide Docket Number: FDA-2018-D-1378 | 2018/05 |
| Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals Docket Number: FDA-2018-D-0721 | 2018/03 |
| Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide Docket Number: FDA-2011-N-0143 | 2018/01 |
| Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities Docket Number: FDA-2017-D-6592 | 2018/01 |
| Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 Docket Number: FDA-2017-D-0397 | 2018/01 |
| Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 15: Supply-Chain Program for Human Food Products Docket Number: FDA-2016-D-2343 | 2018/01 |
| Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs Docket Number: FDA-2017-N-6908 | 2018/01 |
| Guidance for Industry: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide Docket Number: FDA-2013-N-0013 | 2017/11 |
| Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food Docket Number: FDA-2017-D-5996 | 2017/11 |
| Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals Docket Number: FDA-2016-D-1229 | 2017/10 |
| Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 Docket Number: FDA-2017-D-6133 | 2017/10 |
| Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide Docket Number: FDA-2011-N-0921 | 2017/09 |
| Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide Docket Number: FDA-2013-N-1425 | 2017/08 |
| Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule Docket Number: FDA-2013-N-0013 | 2017/08 |
| Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation Docket Number: FDA-2011-N-0143 | 2017/03 |
| Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods Docket Number: FDA-2008-D-0096 | 2017/01 |
| Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) Docket Number: FDA-2012-D-1002 | 2016/11 |
| Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide Docket Number: FDA-2011-N-0920 | 2016/10 |
| Guidance for Industry: Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Docket Number: FDA-2011-N-0922 | 2016/10 |
| Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA Docket Number: FDA-2016-D-2841 | 2016/10 |
| Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) Docket Number: FDA-2012-D-0585 | 2016/09 |
| Draft Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals Docket Number: FDA-2016-D-1229 | 2016/08 |
| Draft Guidance for Industry: Human Food By-Products for Use as Animal Food Docket Number: FDA-2016-D-1220 | 2016/08 |
| Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities Docket Number: FDA-2016-D-2373 | 2016/08 |
| Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food Docket Number: FDA-2016-D-2343 | 2016/08 |
| Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) Docket Number: FDA-2011-N-0179 | 2016/06 |
| Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards Docket Number: FDA-2011-N-0146 | 2015/07 |
| Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide Docket Number: FDA-2013-N-1421 | 2014/04 |
| Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act Docket Number: FDA-2011-D-0674 | 2014/04 |
| Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide Docket Number: FDA-2011-D-0643 | 2013/03 |
| SUPERCEDED: Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide Docket Number: FDA-2012-D-1003 See Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide | 2012/12 |
| Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) Docket Number: FDA-2011-D-0598 | 2012/02 |
| Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act Docket Number: FDA-2011-D-0721 | 2011/09 |
| WITHDRAWN Guidance for Industry: Enforcement Policy Concerning Certain Prior Notice Requirements | 2011/06 |
| Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues Docket Number: FDA-2011-D-0376 | 2016/08 |
| Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance Docket Number: FDA- 2011-D-0287 | 2011/04 |