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  1. Coronavirus Disease 2019 (COVID-19)

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid coronavirus disease 2019 (COVID-19) response efforts.

Process for COVID-19 Related Guidances

In the Federal Register of March 25, 2020, FDA published a Notice announcing the process for making COVID-19 related guidance documents available to the public. The process is in accordance with FDA’s established good guidance practices regulations and will enable FDA to more rapidly disseminate and implement agency recommendations and policies related to COVID-19.

As part of this process, FDA intends to periodically publish a consolidated Notice of Availability (NOA) announcing the availability of all COVID-19-related guidance documents FDA issued during the relevant period. Interested parties can access the NOAs when published in the Federal Register by clicking on the appropriate link contained in the table below listing COVID-19-related guidance documents.

Implementation of COVID-19 Related Guidance Documents

In accordance with FDA’s good guidance practices, FDA will not seek public comment prior to implementing a guidance document if the agency determines that prior public participation is not feasible or appropriate. Guidance documents where prior public participation is not feasible or appropriate are implemented immediately, but remain subject to comment. Although FDA anticipates that it will immediately implement COVID-19 related guidances, FDA will consider all comments received on any guidances and revise the guidance documents when appropriate.


Title Guidance Type Product Area Date Posted
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (Updated July 2, 2020) Final Guidance for Industry, Investigators, and Institutional Review Boards

Drugs
Biologics
Medical Devices

July 2, 2020
Development and Licensure of Vaccines to Prevent COVID-19 Final Guidance for Industry Biologics June 30, 2020
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers Final Guidance for Industry and FDA Staff Biologics
Medical Devices
June 22, 2020
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Final Guidance for Industry Animal & Veterinary
Biologics
Drugs
 
June 19, 2020
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry Final Guidance for Industry Animal & Veterinary
Biologics
Drugs
Medical Devices
June 16, 2020
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency Final Guidance for Industry Drugs June 8, 2020
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Final Guidance for IRBs and Clinical Investigators Drugs
Biologics
June 2, 2020
Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency Final Guidance for Industry Food & Beverages May 27, 2020
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers Final Guidance for Industry

Biologics

Drugs

May 26, 2020
Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices May 26, 2020
Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  Final Guidance for Industry Food & Beverages May 22, 2020
Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines Final Guidance for Industry Food & Beverages May 22, 2020
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff

Biologics

Medical Devices

May 21, 2020
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic Final Guidance for Industry

Animal & Veterinary

Food & Beverages

May 12, 2020
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products Final Guidance for Industry and Investigators

Drugs

Biologics

May 11, 2020
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Final Guidance for Industry

Drugs

Biologics

May 11, 2020
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (Revised) Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and FDA Staff Medical Devices May 11, 2020
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised) Final Guidance for Industry Drugs May 21, 2020
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised) Final Guidance for Industry Drugs May 21, 2020
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic Final Guidance for Industry

Food & Beverages

Drugs

Biologics

Medical Devices

May 8, 2020
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency Final Guidance for Industry Animal & Veterinary May 7, 2020
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices June 19, 2020
Investigational COVID-19 Convalescent Plasma; Guidance for Industry (Updated: May 1, 2020) Final Guidance for Industry Biologics May 1, 2020
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Final Guidance for Industry

Drugs

Biologics

April 30, 2020
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry, Clinical Laboratories, Heathcare Facilities, Pathologists, and FDA Staff Medical Devices April 24, 2020
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 23, 2020
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 23, 2020
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency Final Guidance for Industry Food & Beverages April 22, 2020
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Final Guidance for Industry Drugs April 22, 2020
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 16, 2020
Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 14, 2020
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate Final Product-Specific Guidances for Generic Drug Development Drugs April 13, 2020
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Final Guidance for Industry Drugs May 14, 2020
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency  Final Guidance for Industry Drugs April 20, 2020
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 6, 2020
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 6, 2020
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency Final Guidance for Egg Producers Food & Beverages April 6, 2020
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 5, 2020
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices April 4, 2020
CVM GFI #270 - Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency Final Guidance for Industry Animal & Veterinary April 3, 2020
Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency Final Guidance for Industry Food & Beverages April 3, 2020
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Final Guidance for Industry and FDA Staff Medical Devices May 26, 2020
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency Final Guidance for Industry Biologics April 2, 2020
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Final Guidance for Industry Biologics April 2, 2020
Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Final Guidance for Industry Biologics April 2, 2020
Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency Final Guidance for Industry Food & Beverages April 1, 2020
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices March 30, 2020
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices March 29, 2020
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry Final Guidance for Industry

Drugs

Biologics

March 27, 2020
Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency Final Guidance for Industry Food & Beverages March 26, 2020
CVM GFI #269 - Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak Final Guidance for Industry Animal & Veterinary March 24, 2020
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Final Guidance for Industry Drugs June 1, 2020
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Final Guidance for Industry and FDA Staff Medical Devices March 22, 2020
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals Final Guidance for Industry and Health Care Professionals

Drugs

Biologics

March 22, 2020
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency (Revised) Final Guidance for Industry and FDA Staff Medical Devices June 5, 2020
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)  Final Guidance for Industry Drugs June 1, 2020
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency Final Guidance for Industry

Food & Beverages

Animal & Veterinary

June 4, 2020
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency  Immediately in Effect Guidance for Industry Drugs June 1, 2020

About FDA Guidances

Guidance documents represent the agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. For information on a specific guidance document, please contact the originating office.

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