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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.


Regulatory Impact Analyses (RIAs)

Publication Date Rule Rule Type Docket Topic
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
 
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