Regulatory Impact Analyses (RIA)

The Food and Drug Administration conducts objective economic analyses of all important proposed and final regulations, which includes the Regulatory Impact Analysis (RIA) as well as other analyses mandated by various statutes and executive orders. 

The Department of Health and Human Services describes an RIA as “a well-established and widely-used approach for collecting, organizing, and analyzing data on the impacts of policy options, to promote evidence-based decision-making. It provides an objective, unbiased assessment that is an essential component of policy development, considering both quantifiable and unquantifiable impacts. Along with information on legal requirements, general policy goals, the distribution of the impacts, and other concerns, it forms the basis of the ultimate policy decision.

The RIA describes the effects of the regulation rather than advocating a particular approach. The arguments supporting the agency’s decision are provided separately in the preamble to the Federal Register notice for the proposed and final regulation. The core of the RIA is an assessment of the benefits and costs of regulatory and other policy options in comparison to a “without regulation” (or “no action”) baseline. In addition, the RIA includes supplementary analyses that respond to various statutory and administrative requirements.”

For more information about the RIA’s purpose, structure, and content, the Department of Health and Human Services provides Guidelines for Regulatory Impact Analysis.

The table below provides all RIAs from 2012 to present. Pre-2012 RIAs were published in the Federal Register.

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Regulatory Impact Analyses (RIAs)

Rule Type ProposedFinalInterim Final

Topic TobaccoGood Manufacturing Practices (GMPs)RadiologicalStandardsHuman DrugFoodReportingClinical Trials and StudiesFood Safety Modernization Act (FSMA)ImportDeviceNutritionLabelingAnimalAnimal DrugMedical GasesBiologicLaboratoryOver-the-Counter (OTC)ClassificationTissuesTestingCompoundingFood and Drug Administration Safety and Innovation Act (FDASIA)Postmarket

Publication Date	Rule	Rule Type	Docket	Topic
12/27/2024	Nutrient Content Claims; Definition of Term “Healthy” (Final Rule)	Final	FDA-2016-D-2335	nutrition, food, labeling
11/08/2024	Color Additive Certification; Increase in Fees for Certification Services	Final	FDA-2022-N-1635	Food Additives; Testing
08/30/2024	Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age (Final Rule)	Final	FDA-2020-N-1395	Tobacco
08/16/2024	Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products RIA (Proposed Rule)	Proposed	FDA-2024-N-1111	Tobacco; import
07/03/2024	Revocation of Authorization for Use of Brominated Vegetable Oil in Food (Final Rule)	Final	FDA-2023-N-0937	Food
06/18/2024	Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases (Final Rule)	Final	FDA-2021-N-1333	Human Drug, Animal Drug
05/31/2024	Administrative Destruction Regulatory Impact Analysis (Final Rule)	Final	FDA-2021-N-1348	Device; Import
05/06/2024	Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Final Regulatory Impact Analysis)	Final	FDA-2021-N-0471	Food; Food Safety Modernization Act (FSMA); Standards
04/29/2024	Laboratory Developed Tests Regulatory Impact Analysis (Final Rule)	Final	FDA-2023-N-2177	device; laboratory; testing
3/22/2024	Food Additives: Food Contact Substance Notification That Is No Longer Effective	Final	FDA-2021-N0403	Food Additives: Food Contact Substance
3/26/2024	Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Proposed Rule)	Proposed	FDA-2023-N-3902	Device
3/20/2024	Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act RIA (Proposed Rule)	Proposed	FDA-2023-N-0061	human drug; compounding
3/15/2024	Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality (Final Rule)	Final	FDA-2020-N-1690	food; standards
3/12/2024	Labeling Requirements for Approved and Conditionally Approved New Animal Drugs (Proposed Rule)	Proposed	FDA-2023-N-5160	animal; animal drug; labeling
12/14/2023	Direct Final Rule to Revoke Use of Partially Hydrogenated Oils in Foods	Direct Final Rule	FDA-2019-N-4750	Food, Nutrition
02/02/2024	Medical Devices; Quality System Regulation Amendments; Final Regulatory Impact Analysis	Final	FDA-2021-N-0507	Device
2/12/2024	Biologics License Applications and Master Files (Final Rule)	Final	FDA-2019-N-1363	biologic; application
12/21/2023	Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations	Final	FDA-2018-N-2727	IRBs and clinical investigations
11/30/2023	Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes RIA (Proposed Rule)	Proposed	FDA–2023–N–3392	device; classification
11/21/2023	Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format	Final Rule	FDA-2009-N-0582	human drug; advertisements
11/03/2023	Revocation of Authorization for Use of Brominated Vegetable Oil in Food (Proposed Rule)	Proposed	FDA-2023-N-0937	food; nutrition
11/01/2023	Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions RIA (Proposed Rule)	Proposed	FDA–2011–N–0179	food; import
9/29/2023	Laboratory Developed Tests Regulatory Impact Analysis (Proposed Rule)	Proposed	FDA-2023-N-2177	device;laboratory;testing
8/25/2023	Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container RIA	Proposed	FDA-2016-P-0147	food; standards
8/8/2023	Direct Final Rule for Revocation of Uses of Partially Hydrogenated Oils in Foods	Direct Final Rule	FDA-2019-N-4750	food; nutrition
8/8/2023	Proposed Rule for Revocation of Uses of Partially Hydrogenated Oils in Foods	Proposed	FDA-2019-N-4750	food; nutrition
5/31/2023	Medication Guides: Patient Medication Information (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2019-N-5959	human drug; labeling
3/30/2023	Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures (Final Rule) Final Regulatory Impact Analysis	Final	FDA-2021-N-0310	device; classification
3/29/2023	Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2022-N-2226	food; nutrition; standards
3/10/2023	Requirements for Tobacco Product Manufacturing Practice (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2013-N-0227	Tobacco; Good Manufacturing Practices (GMPs)
3/10/2023	Mammography Quality Standards Act; Amendments to Part 900 Regulations (Final Rule) Regulatory Impact Analysis (FRIA)	Final	FDA-2013-N-0134	radiological; standards
1/20/2023	Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products (Final Rule) Regulatory Impact Analysis	Final	FDA-2018-N-3303	radiological; standards
12/9/2022	Investigational New Drug Application Annual Reporting (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2020-N-0258	human drug; reporting
12/9/2022	Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA–2019–N–2650	human drug; food; Food Safety Modernization Act (FSMA); standards
11/21/2022	Requirements for Additional Traceability Records for Certain Foods (Final Rule) Regulatory Impact Analysis	Final	FDA-2014-N-0053	food; Food Safety Modernization Act (FSMA); standards
11/4/2022	Color Additive Certification; Increase in Fees for Certification Services (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2022-N-1635	food
10/18/2022	Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices (Final Rule) Regulatory Impact Analysis	Final	FDA-2018-N-4268	food; import
10/7/2022	Administrative Destruction (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2021-N-1348	device; import
9/29/2022	Nutrient Content Claims; Definition of Term “Healthy” (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2016-D-2335	food; nutrition; labeling
9/28/2022	Institutional Review Boards: Cooperative Research (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2019-N-2175	human drug; clinical trials and studies
9/28/2022	Protection of Human Subjects and Institutional Review Boards (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2021-N-0286	human drug; clinical trials and studies
9/15/2022	Defining ‘Small Number of Animals’ for Minor Use Determination; Periodic Reassessment (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2022-N-1128	animal; animal drug
9/15/2022	Defining ‘Small Number of Animals’ for Minor Use Determination; Periodic Reassessment (Direct Final Rule) Regulatory Impact Analysis	Final	FDA-2022-N-1128	animal; animal drug
9/14/2022	Annual Summary Reporting Requirements Under the Right to Try Act (Final Rule) Regulatory Impact Analysis	Final	FDA-2019-N-5553	human drug; clinical trials and studies; reporting
8/17/2022	Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids (Final Rule) Regulatory Impact Analysis	Final	FDA-2021-N-0555	device; over-the-counter (otc)
7/25/2022	Revising the National Drug Code Format and Drug Label Barcode Requirements (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2021-N-1351	biologic; human drug; labeling
7/19/2022	Supplemental Notice of Proposed Rulemaking: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2021-N-0471	food; Food Safety Modernization Act (FSMA); standards
7/15/2022	Revocation of Methods of Analysis Regulation (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2020-N-1383	food; human drug; testing
6/22/2022	Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Proposed Rule) Regulatory Impact Analysis	Proposed	FDA-2021-N-0862	human drug; labeling
5/23/2022	Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-1333	human drug; good manufacturing practices (GMPs); medical gases
5/4/2022	Tobacco Product Standard for Menthol in Cigarettes (Proposed Rule), Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-1349	tobacco; standards
5/4/2022	Tobacco Product Standard for Characterizing Flavors in Cigars (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-1309	tobacco; standards
4/20/2022	Final Rule to Revise the Allowable Level of Fluoride in Bottled Water to which Fluoride Has Been Added, Final Regulatory Impact Analysis	Final	FDA-2018-N-1815	nutrition;
2/23/2022	Medical Devices; Quality System Regulation Amendments (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-0507	device; labeling
2/4/2022	National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers (Proposed Rule)	Proposed	FDA-2020-N-1663	human drug; reporting
1/26/2022	Food Additives: Food Contact Substance Notification That Is No Longer Effective (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-0403	food;
1/21/2022	Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-0851	device; classification
1/18/2022	Amendment to Add a New Method for the Analysis of Sulfites in Food (Final Rule) Final Regulatory Impact Analysis (FRIA)	Final	FDA-2019-N-0463	food; testing
1/13/2022	Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications (Final Rule) Regulatory Impact Analysis	Final	FDA-2019-N-3101	device; application
1/13/2022	French Dressing; Revocation of a Standard of Identity (Final Rule) Final Regulatory Impact Analysis (FRIA)	Final	FDA-2020-N-1807	food; standards
1/13/2022	Revocation of the Human Tissue Intended for Transplantation Regulations and Human Dura Mater (Final Rule) Regulatory Impact Analysis	Final	FDA-2020-N-1519	biologic; tissues
12/16/2021	Classification of Spinal Sphere Devices (Proposed Rule)	Proposed	FDA-2021-N-0310	device; classification
12/3/2021	Laboratory Accreditation for Analyses of Foods, Final Regulatory Impact Analysis	Final	FDA-2019-N-3325	food; laboratory
12/2/2021	Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Proposed Rule) Preliminary Regulatory Impact Analysis	Proposed	FDA-2021-N-0471	food; Food Safety Modernization Act (FSMA); standards
10/20/2021	OTC Hearing Aids (Proposed Rule)	Proposed	FDA-2021-N-0555	device; over-the-counter (otc)
10/5/2021	Premarket Tobacco Product Applications and Recordkeeping Requirements (Final Rule) Regulatory Impact Analysis	Final	FDA-2019-N-2854	tobacco; application
10/5/2021	Medical Device De Novo Classification Process (Final Rule)	Final	FDA-2018-N-0236	tobacco; application
10/4/2021	Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Final Rule; Final Regulatory Impact Analysis	Final	FDA-2016-N-3818	tobacco; reporting
9/21/2021	Import Tolerances for Residues of Unapproved New Animal Drugs in Food (Final Rule)	Final	FDA-2001-N-0075	animal; animal drug; import
8/2/2021	Regulations Regarding "Intended Uses" (Final Rule)	Final	FDA- 2015-N-2002	device; human drug; classification
12/21/2020	French Dressing; Proposed Revocation of a Standard of Identity (Proposed Rule) Preliminary Regulatory Impact Analysis (PRIA)	Proposed	FDA-2020-N-1807	food; standards
12/21/2020	Revocation of the Human Tissue Intended for Transplantation Regulations and Human Dura Mater (Proposed Rule)	Proposed	FDA-2020-N-1519	biologic; tissues
12/18/2020	Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality (Proposed Rule)	Proposed	FDA-2020-N-1690	food; standards
9/25/2020	Importation of Prescription Drugs (Final Rule)	Final	FDA-2019-N-5711	human drug; import
9/23/2020	Requirements for Additional Traceability Records for Certain Foods (Proposed Rule)	Proposed	FDA-2014-N-0053	food; Food Safety Modernization Act (FSMA);standards
9/23/2020	Intended Uses (Proposed Rule)	Proposed	FDA-2015-N-2002	device; human drug; classification
8/21/2020	Revocation of the Test for Mycoplasma (Final Rule)	Final	FDA-2018-N-4757	biologic; testing
8/13/2020	Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods (Final Rule)	Final	FDA-2014-N-1021	food; nutrition; labeling
8/3/2020	Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices (Proposed Rule)	Proposed	FDA-2018-N-4268	animal; device; import
7/29/2020	Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule)	Final	FDA-2017-N-6381	animal; animal drug; postmarket
7/24/2020	Annual Summary Reporting Requirements Under the Right to Try Act (Proposed Rule)	Proposed	FDA-2019-N-5553	biologic; human drug
3/18/2020	Tobacco Products; Required Warnings for Cigarette Packages and Advertisements (Final Rule)	Final	FDA-2019-N-3065	tobacco; labeling
3/6/2020	Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (Final Rule)	Final	FDA-2016-N-1111	device;
2/21/2020	Definition of the Term “Biological Product” (Final Rule)	Final	FDA-2018-N-2732	biologic;
12/23/2019	Importation of Prescription Drugs (Proposed Rule)	Proposed	FDA-2019-N-5711	human drug; import
12/17/2019	Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications (Proposed Rule)	Proposed	FDA-2019-N-3101	device; application
12/16/2019	Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Final Rule)	Final	FDA-2017-N-6924	human drug; application
12/13/2019	Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format (Final Rule)	Final	FDA-2018-N-0628	device; application
11/4/2019	Accreditation of Laboratories to Conduct Food Testing (Proposed Rule)	Proposed	FDA-2019-N-3325	food; laboratory
10/28/2019	Food Labeling: Calorie Labeling of Articles of Food Sold from Certain Vending Machines; Front of Package Type Size (Final Rule)	Final	FDA-2011-F-0171	food; nutrition; labeling
9/25/2019	Premarket Tobacco Product Applications and Recordkeeping Requirements (Proposed Rule)	Proposed	FDA-2019-N-2854	tobacco; application
9/17/2019	Amendment to Add a New Method for the Analysis of Sulfites in Foods (Proposed Rule)	Proposed	FDA-2019-N-0463	food; testing
9/5/2019	Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule)	Proposed	FDA-2018-N-4845	human drug; compounding
8/16/2019	Tobacco Products; Required Warnings for Cigarette Packages and Advertisements (Proposed Rule)	Proposed	FDA-2019-N-3065	tobacco; labeling
7/11/2019	New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food (Final Rule)	Final	FDA-2012-N-1067	animal; animal drug
6/28/2019	Biologics License Applications and Master Files (Proposed Rule)	Proposed	FDA-2019-N-1363	biologic; application
4/12/2019	Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Final Rule)	Final	FDA-2016-N-0124	human drug; over-the-counter (otc); reporting
4/3/2019	Proposed Rule to Revise the Allowable Level of Fluoride in Bottled Water to which Fluoride Has Been Added	Proposed	FDA-2018-N-1815	nutrition;
4/2/2019	Elimination of 21 CFR 610.30 Test for Mycoplasma (Proposed Rule)	Proposed	FDA-2018-N-4757	biologic; testing
4/2/2019	Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products (Final Rule)	Final	FDA-2017-N-7007	biologic;
4/2/2019	Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports (Proposed Rule)	Proposed	FDA-2016-N-3818	tobacco; reporting
4/1/2019	Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products (Proposed Rule)	Proposed	FDA-2018-N-3303	device;
4/1/2019	Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems (Final Rule)	Final	FDA-2015-N-3785	device; classification
4/1/2019	Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Final Rule)	Final	FDA-2011-N-0103	device; classification
3/27/2019	Mammography Quality Standards Act; Amendments to Part 900 Regulations (Proposed Rule)	Proposed	FDA-2013-N-0134	device; standards
3/18/2019	Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E (Final Rule)	Final	FDA-2011-N-0921	food; Food Safety Modernization Act (FSMA); standards
2/26/2019	Sunscreen Drug Products for Over-the-Counter Human Use; Proposal to Amend and Lift Stay on Monograph (Proposed Rule)	Proposed	FDA-1978-N-0018	human drug; over-the-counter (otc); labeling
2/15/2019	List of Bulk Drug Substances That Can Be Used Compound Drug Products in Accordance With Section 503A of the Federal Food Drug and Cosmetic Act (Final Rule)	Final	FDA-2016-N-3464	human drug; compounding
12/17/2018	Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures (Final Rule)	Final	FDA-2013-N-1529	device; classification; Food and Drug Administration Safety and Innovation Act (FDASIA)
12/12/2018	Definition of the Term "Biological Product" (Proposed Rule)	Proposed	FDA-2018-N-2732	biologic;
12/11/2018	Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Final Rule)	Final	FDA-2016-N-2462	human drug; postmarket
12/11/2018	Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Final Rule)	Final	FDA-2016-N-2462	human drug; postmarket
12/7/2018	Medical Device De Novo Classification Process (Proposed Rule)	Proposed	FDA-2018-N-0236	device; classification
11/15/2018	Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Proposed Rule)	Proposed	FDA-2018-N-2727	human drug; device; clinical trials and studies
9/13/2018	Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format (Proposed Rule)	Proposed	FDA-2018-N-0628	device; application
9/12/2018	Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Proposed Rule)	Proposed	FDA-2017-N-6924	human drug; over-the-counter (otc); application
7/12/2018	Food Labeling; Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size (Proposed Rule)	Proposed	FDA-2011-F-0171-0281	food; nutrition; labeling
5/18/2018	Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories (Final Rule)	Final	FDA-2016-N-0406	blood; device; classification
5/15/2018	Amendments to 21 CFR Part 3 - Product Jurisdiction (Proposed Rule)	Proposed	FDA-2004-N-0191	human drug; device; classification
5/4/2018	Crabmeat; Amendment of Common or Usual Name Regulation (Final Rule)	Final	FDA-2018-N-1438	food; labeling
5/4/2018	Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates (Final Rule)	Final	FDA-2012-N-1210 and FDA-2004-N-0258	food; nutrition; labeling
3/16/2018	Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses;" Partial Delay of Effective Date (Final Rule)	Final	FDA-2015-N-2002	tobacco; classification
2/21/2018	Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices (Final Rule)	Final	FDA- 2013-N-0080	device; clinical trials and studies
2/14/2018	Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Proposed Rule)	Proposed	FDA-2017-N-6381-0001	animal; animal drug; postmarket
1/26/2018	Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products (Proposed Rule)	Proposed	FDA-2017-N-7007	biologic;
1/17/2018	Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by Center for Devices and Radiological Health (Proposed Rule)	Proposed	FDA-2016-N-2378	device;
12/28/2017	New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator (Final Rule)	Final	FDA–2011–N–0079	animal; animal drug; clinical trials and studies
12/20/2017	Safety and Effectiveness for Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Final Rule)	Final	FDA-2015-N-0101	human drug; over-the-counter (otc); reporting
10/31/2017	Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease (Proposed Rule)	Proposed	FDA-2017-N-0763	food; nutrition; labeling
10/2/2017	Nutrition Facts Label and Serving Size; Extension of Compliance Dates (Proposed Rule)	Proposed	FDA-2012-N-1210 and FDA-2004-N-0258	food; nutrition; labeling
9/13/2017	Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E; Proposed Rule (Proposed Rule)	Proposed	FDA–2011–N–0921	food; Food Safety Modernization Act (FSMA); standards
5/5/2017	Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date and Request for Comments (Interim Final Rule)	Interim Final	FDA-2011-F-0172	food; nutrition; labeling
1/9/2017	Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" (Final Rule)	Final	FDA-2015-N-2002	tobacco; classification
1/9/2017	Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products (Proposed Rule)	Proposed	FDA-2016-N-2527	tobacco; standards
12/30/2016	Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date (Final Rule)	Final	FDA-2011-F-0172	tobacco; standards
12/20/2016	Postmarketing Safety Reporting for Combination Products (Final Rule)	Final	FDA-2008-N-0424	human drug; device; postmarket
12/19/2016	Banned Devices; Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove (Final Rule)	Final	FDA-2015-N-5017	device;
12/19/2016	General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Final Rule)	Final	FDA-2015-N-0701	device; classification
12/19/2016	Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (Interim Final Rule)	Interim Final	FDA-2013-P-0047	food; nutrition; labeling
12/16/2016	List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act; Criteria and List (Proposed Rule)	Proposed	FDA-2016-N-3464	human drug; compounding
11/29/2016	Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (Final Rule)	Final	FDA-2016-N-1487	food; human drug; import
10/17/2016	Electronic Submission of Labeling for Certain Home-Use Medical Devices (Proposed Rule)	Proposed	FDA-2016-N-2491	device; labeling
10/6/2016	Abbreviated New Drug Applications and 505(b)(2) Applications (Final Rule)	Final	FDA-2011-N-0830	human drug; animal drug; application
9/6/2016	Abbreviated New Drug Applications and 505(b)(2) Applications Use (Final Rule)	Final	FDA-1975-N-0012	human drug; animal drug; application
8/31/2016	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs (Final Rule)	Final	FDA-2005-N-0464	human drug; biologic; registration
8/24/2016	Good Laboratory Practice for Nonclinical Laboratory Studies	Proposed	FDA-2010-N-0548-0088	food; human drug; laboratory
8/17/2016	Substances Generally Recognized as Safe (Final Rule)	Final	FDA-1997-N-0020 (formerly 97N-0103)	food
8/1/2016	Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date	Final	FDA-2011-F-0171	food; nutrition; labeling
7/14/2016	Amendments to Registration of Food Facilities (Final Rule)	Final	FDA-2002-N-0323	food; registration
7/1/2016	Submission of FDA Import Data in the Automated Commercial Environment (Proposed Rule)	Proposed	FDA-2016-N-1487	food; human drug; import
6/30/2016	Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph	Proposed	FDA-2016-N-0124 (Formerly Part of Docket No. FDA-1975-N-0012)	human drug; over-the-counter (otc); reporting
6/15/2016	Use of Symbols in Labeling (Final Rule)	Final	FDA-2013-N-0125	device; biologic; labeling
5/27/2016	Food Labeling: Revision of the Nutrition and Supplement Facts Labels (Final Rule) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Final Rule)	Final	FDA-2004-N-0258, FDA-2012-N-1210	food; nutrition; labeling
5/26/2016	Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule)	Final	FDA-2013-N-1425	food; Food Safety Modernization Act (FSMA); adulteration
5/11/2016	Antimicrobial Animal Drug Sales and Distribution Reporting (Final Rule)	Final	FDA-2012-N-0447, 0910-AG45	animal; animal drug; reporting
5/10/2016	Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco	Final	FDA-2012-N-0920	tobacco; reporting
4/25/2016	Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior (Proposed Rule)	Proposed	FDA-2016-N-1111	device
4/25/2016	Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements (Final Rule)	Final	FDA-2014-N-0189	tobacco; classification
4/6/2016	Sanitary Transportation of Human and Animal Food (Final Rule)	Final	FDA-2013-N-0013	food; Food Safety Modernization Act (FSMA); standards
4/4/2016	Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (Proposed Rule)	Proposed	FDA-2016-N-0543	human drug; over-the-counter (otc); application
3/22/2016	Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove (Proposed Rule)	Proposed	FDA-2015-N-5017	device
12/23/2015	Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Proposed Rule)	Proposed	FDA-2015-N-1260	human drug; over-the-counter (otc); application
12/22/2015	Sunlamp Products; Proposed Amendment to Performance Standard (Proposed Rule)	Proposed	FDA-1998-N-0880	device; standards
12/22/2015	General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products (Proposed Rule)	Proposed	FDA-2015-N-1765	device
11/18/2015	Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods (Proposed Rule)	Proposed	FDA-2014-N-1021	food; nutrition; labeling
11/17/2015	Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Proposed Rule)	Proposed	FDA-2011-N-0103	device; classification
11/13/2015	Standards for the Growing, Harvesting, Packing,and Holding of Produce for Human Consumption (Final Rule)	Final	FDA–2011–N–0921	food; Food Safety Modernization Act (FSMA); standards
11/13/2015	Foreign Supplier Verification Program (Final Rule)	Final	FDA-2011-N-0143	food; Food Safety Modernization Act (FSMA); import
11/13/2015	Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Final Rule)	Final	FDA-2011-N-0146	food; Food Safety Modernization Act (FSMA)
10/8/2015	General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet (Proposed Rule)	Proposed	FDA-2015-N-0701	device; classification
9/25/2015	Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" (Proposed Rule)	Proposed	FDA-2015-N-2002	tobacco; classification
9/24/2015	National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions (Final Rule)	Final	FDA-2013-N-1282	tobacco
9/17/2015	FSMA Final Rulemaking for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Final Rule)	Final	FDA-2011-N-0922	animal; Food Safety Modernization Act (FSMA); good manufacturing practices (GMPs)
9/17/2015	Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Final Rule)	Final	FDA-2011-N-0920	food; Food Safety Modernization Act (FSMA); good manufacturing practices (GMPs)
9/15/2015	Administrative Destruction of Certain Drugs Refused Admission to the United States (Final Rule)	Final	FDA-2014-N-0504	human drug; animal drug; import
7/27/2015	Food Labeling: Revision of The Nutrition and Supplement Facts Labels and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Proposed Rule)	Proposed	FDA-2012-N-1210	food; nutrition; labeling
7/10/2015	Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date (Final Rule)	Final	FDA-2011-F-0172	food; nutrition; labeling
7/8/2015	Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (Final Rule)	Final	FDA-2011-N-0898	biologic; human drug; reporting
6/23/2015	The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements (Final Rule)	Final	FDA-2013-N-0067	food; nutrition; standards
6/3/2015	Veterinary Feed Directive (Final Rule)	Final	FDA-2010-N-0155	animal; animal feed
5/22/2015	Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (Final Rule)	Final	FDA-2006-N-0040 (formerly Docket No. 2006-N-0221)	blood; standards
5/20/2015	Antimicrobial Animal Drug Sales and Distribution Reporting (Proposed Rule)	Proposed	FDA-2012-N-0447; 0910-AG45	animal; animal drug; reporting
5/1/2015	Designation of Official Names and Proper Names for Certain Biological Products (Proposed Rule)	Proposed	FDA-2015-N-0101	biologic
5/1/2015	Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record (Proposed Rule)	Proposed	FDA-2015-N-0101	human drug; over-the-counter (otc); reporting
4/9/2015	Amendments to Registration of Food Facilities (Proposed Rule)	Proposed	FDA-2002-N-0323	food; registration
2/6/2015	Abbreviated New Drug Applications and 505(b)(2) Applications (Proposed Rule)	Proposed	FDA-2011-N-0830	human drug; animal drug; application
12/18/2014	Electronic Distribution of Prescribing Information for Human Prescriptions Drugs, Including Biological Products (Proposed Rule)	Proposed	FDA-2007-N-0363-0040	biologic; human drug; prescription
12/4/2014	Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling; Final Rule	Final	FDA-2006-N-0515 (formerly docket no. 2006N-0467)	biologic; human drug; labeling
12/1/2014	Food Labeling: Calorie Labeling of Articles of Food in Vending (Final Rule)	Final	FDA-2011-F-0171	food; nutrition; labeling
12/1/2014	Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Final Rule)	Final	FDA-2011-F-0172	food; nutrition; labeling
9/29/2014	FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Supplemental Proposed Rule)	Proposed	FDA-2011-N-0920	food; Food Safety Modernization Act (FSMA); good manufacturing practices (GMPs)
9/29/2014	FSMA Supplemental Notice of Proposed Rulemaking for Foreign Supplier Verification Programs	Proposed	FDA-2011-N-0146	food; Food Safety Modernization Act (FSMA); import
9/29/2014	FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals	Proposed	FDA-2011-N-0922	animal; Food Safety Modernization Act (FSMA); good manufacturing practices (GMPs)
9/29/2014	FSMA Supplemental Notice of Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption	Proposed	FDA-2011-N-0921	food; Food Safety Modernization Act (FSMA); standards
7/10/2014	Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products (Final Rule)	Final	FDA-2012-N-0920	tobacco; reporting
6/10/2014	Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements (Final Rule)	Final	FDA-2008-N-0334	human drug; biologic; postmarket
6/10/2014	Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Final Rule)	Final	FDA-1995-N-0063	food; good manufacturing practices (GMPs)
5/30/2014	Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex (Final Rule)	Final	FDA-2013-N-0544	device; classification
5/29/2014	Administrative Detention of Drugs Intended for Human or Animal Use (Final Rule)	Final	FDA-2013-N-0365	human drug; animal drug; import
5/6/2014	Administrative Destruction of Certain Drugs Refused Admission to the United States (Proposed Rule)	Proposed	FDA-2014-N-0504	human drug; animal drug; import
4/25/2014	Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (Proposed Rule)	Proposed	FDA-2014-N-0189	tobacco; classification
3/3/2014	Food Labeling: Revision of the Nutrition and Supplement Facts Labels (Proposed Rule) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Proposed Rule)	Proposed	FDA-2012-N-1210, FDA-2004-N-0258	food; nutrition; labeling
2/14/2014	Medical Device Reporting: Electronic Submission Requirements (Final Rule)	Final	FDA-2008-N-0393	device; reporting
2/10/2014	Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula (Interim Final Rule)	Interim Final	FDA-1995-N-0063	food; good manufacturing practices (GMPs)
2/5/2014	Sanitary Transportation of Human and Animal Food (Proposed Rule)	Proposed	FDA-2013-N-0013	food; Food Safety Modernization Act (FSMA); standards
12/24/2013	Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule)	Final	FDA-2013-N_1425	food; Food Safety Modernization Act (FSMA); adulteration
12/17/2013	Consumer Antiseptic Washes	Proposed	FDA-1975-N-0012 (Formerly 1975N-0183H)	human drug; over-the-counter (otc); reporting
12/11/2013	Veterinary Feed Directive	Proposed	FDA-2010-N-0155	animal; animal feed
11/13/2013	Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products	Proposed	FDA-2013-N-0500	human drug; biologic; labeling
11/4/2013	Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Proposed Rule	Proposed	FDA-2011-N-0898	human drug; biologic; reporting
10/29/2013	Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals	Proposed	FDA-2011-N-0922	animal; Food Safety Modernization Act (FSMA); good manufacturing practices (GMPs)
9/24/2013	Unique Device Identification System Final Rule	Final	FDA-2011-N-0090	device; labeling
8/5/2013	Food Labeling; Gluten-Free Labeling of Foods	Final	FDA-2005-N-0404	food; nutrition; labeling
7/31/2013	Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors/ Certification Bodies	Proposed	FDA-2011-N-0143, FDA-2011-N-0146	food; Food Safety Modernization Act (FSMA); import
7/12/2013	Administrative Detention of Drugs Intended for Human or Animal Use	Proposed	FDA-2013-N-0365	human drug; animal drug; import
6/19/2013	Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex	Proposed	FDA-2013-N-0559	device; classification
4/19/2013	Use of Certain Symbols in Labeling	Proposed	FDA-2013-N-0125	device; labeling
2/26/2013	Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products	Final	FDA-2000-N-0009 (formerly FDA-2000-N-0074)	device; human drug; clinical trials and studies
2/25/2013	Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices	Proposed	FDA-2013-N-0080	device; clinical trials and studies
1/4/2013	Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption	Proposed	FDA-2011-N-0921	food; Food Safety Modernization Act (FSMA); standards
1/4/2013	Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food	Proposed	FDA-2011-N-0920	food; Food Safety Modernization Act (FSMA); good manufacturing practices (GMPs)
11/19/2012	Unique Device Identification System	Proposed	FDA-2011-N-0090	device; labeling
3/19/2012	Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis complex	Proposed	FDA-2012-N-0159	device; classification