FSMA Rules & Guidance for Industry

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FSMA Rules & Guidance for Industry

Rules

Title Issued Date
Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
Docket Number: FDA-2011-N-0921
2017/09
Final Rule: Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program
Docket Number: FDA-2011-N-0146
2017/01
Final Rule: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Docket Number: FDA-2011-N-0920FDA-2011-N-0921FDA-2011-N-0922FDA-2011-N-0143
2016/08
Final Rule: Amendments to Registration of Food Facilities
Docket Number: FDA-2002-N-0323
2016/07
Final Rule: Mitigation Strategies to Protect Food Against Intentional Adulteration
Docket Number: FDA-2013-N-1425
2016/05
Final Rule: Sanitary Transportation of Human and Animal Food
Docket Number: FDA-2013-N-0013
2016/04
Final Rule: Accredited Third-Party Certification
Docket Number: FDA-2011-N-0146
2015/11
Final Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Docket Number: FDA-2011-N-0921
2015/11
Final Rule: Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
Docket Number: FDA-2011-N-0143
2015/11
Final Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
Docket Number: FDA-2011-N-0920

2015/09
Final Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Docket Number: FDA-2011-N-0922
2015/09
Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
Docket Number: FDA-2011-N-0146
Correction Notice
2015/07
Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
Docket Number: FDA-2002-N-0153 (Formerly Docket No. 2002N-0277)
2014/04
Advance Notice of Proposed Rulemaking: Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act
Docket Number: FDA-2013-N-0590
2014/03
Final Rule: Information Required in Prior Notice of Imported Food 
Docket Number: FDA-2011-N-0179
2013/05
Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
Docket Number: FDA-2011-N-0197
2013/02

Guidance for Industry & Others

Title Issued Date
Draft 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
2018/01
Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Docket Number: FDA-2017-D-5225
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: #245 – Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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: 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
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
Docket Number: FDA-2017-D-6528
2017/12
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
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: Current Good Manufacturing Practice Requirements for Food for Animals
Docket Number: FDA-2016-D-1229
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: Juice HACCP and the FDA Food Safety Modernization Act
Docket Number: FDA-2017-D-3716
2017/08
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
2017/08
Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
Docket Number: FDA-2017-D-3716
2017/08
Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation
Docket Number: FDA-2011-N-0143
2017/05
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: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations
Docket Number: FDA-2017-D-0175
2017/01
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods
Docket Number: FDA-2008-D-0096
2017/01
Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
Docket Number: FDA-2011-N-0146
2016/12
Guidance for Industry: FDA’s Voluntary Qualified Importer Program
Docket Number: FDA-2011-N-0144
2016/11
Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
Docket Number: FDA-2012-D-1002
2016/11
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: 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: 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: New Dietary Ingredient Notifications and Related Issues
Docket Number: FDA-2011-D-0376
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
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
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: Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
Docket Number: FDA-2016-D-1164
2016/05
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
Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
Docket Number: FDA-2015-D-0138
2015/05
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
Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide
Docket Number: FDA-2012-D-1003
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
Guidance for Industry: Enforcement Policy Concerning Certain Prior Notice Requirements 2011/06
Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
Docket Number: FDA- 2011-D-0287
2011/04

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