The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical devices, drugs and biological products, and foods during the public health emergency. Several of these guidance documents have been modified, updated, or withdrawn as circumstances have changed, and on March 13, 2023, the FDA issued a notice in the Federal Register that outlines how it intends to unwind a large swath of COVID-19-related guidance documents that are still in effect. FDA sorted 72 COVID-19-related guidance’s into several categories, based on how long and in what form they will continue to be in effect after the expiration of the public health emergency (PHE) declaration, which is expected on May 11, 2023.
1. Guidances that will no longer be in effect upon expiration of the COVID-19 PHE declaration
FDA identifies the following 22 guidance documents that will no longer be in effect upon expiration of the COVID-19 PHE declaration on May 11, 2023, noting its determination that these guidances are no longer needed because their recommendations have been incorporated in other guidance documents and/or stakeholders are no longer relying on them as evolving COVID-19 conditions have allowed more customary operations to resume.
| Lead Center | Title of Guidance |
| Center for Biologics Evaluation and Research (CBER) | Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency |
| Center for Drug Evaluation and Research (CDER) | COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation TunnelsNonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 PandemicDevelopment of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and AnswersProtecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health EmergencyReview Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for IndustryResuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health EmergencyGood Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products ManufacturingStatistical Considerations for Clinical Trials During the COVID-19 Public Health EmergencyEffects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and AnswersTemporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health EmergencyTemporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for IndustryTemporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health EmergencyTemporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health EmergencyCOVID-19 Public Health Emergency: General Considerations for Pre- IND Meeting Requests for COVID-19 Related Drugs and Biological ProductsExemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency |
| Center for Devices and Radiological Health (CDRH) | 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 (Revised)Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency |
| Center for Food Safety and Applied Nutrition (CFSAN) | Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health EmergencyTemporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health EmergencyTemporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health EmergencyReporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency |
The Agency specifically notes that with respect to the withdrawal of the guidance regarding exemption and exclusion from certain requirements of the Drug Supply Chain and Security Act (DSCSA), the Agency retains authority under the DSCSA to grant waivers, exemptions, and exceptions, as needed, to avoid disruption and allow continued distribution of covered products beyond the expiration of the PHE declaration.
2. Guidances that FDA is revising to continue in effect for 180 days (or potentially longer) after the PHE declaration expires
FDA identifies a second category of guidance documents that will be discontinued in connection with the expiration of the PHE declaration, but with a 180-day wind-down period to allow for “orderly transition.” The Agency identifies the following seven guidance documents that will continue in effect for 180 days after the PHE declaration expires and will no longer be in effect after November 7, 2023.
| Lead Center | Title of Guidance |
| CDER | 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 Guidance for IndustryManufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and AnswersPolicy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
| CFSAN | Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health EmergencyTemporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending MachinesTemporary 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 |
| Center for Veterinary Medicine (CVM) | CVM GFI #270—Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency |
The Agency also identifies the following 15 enforcement policy guidance documents that will continue in effect for 180 days after the PHE declaration expires, unless FDA provides a different intended duration once FDA finalizes the Agency’s draft guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” (December 2021). For these guidance documents, FDA indicates that it intends to finalize the draft device enforcement policy transition guidance “as soon as practicable.” For details of FDA’s proposed transition plan for these guidance’s, see our prior Alert discussing the details of FDA’s draft device enforcement policy transition guidance.
| Lead Center | Title of Guidance |
| CDRH | Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID- 19) Public Health EmergencyCoagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
3. Guidances that FDA plans to revise within 180 days following the expiration of the PHE declaration
FDA identifies the following 24 COVID-19-related guidance documents that it plans to update and retain after the expiration of the PHE declaration. The Agency indicates that these guidances will remain in effect for 180 days after the expiration of the PHE declaration, and that anytime within those 180 days, the Agency will further revise each guidance based on comments received and the Agency’s experience with implementation. Of note, this category includes the guidance regarding the conduct of clinical trials of medical products and the guidance regarding remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities.
| Lead Center | Title of Guidance |
| CBER | Emergency Use Authorization for Vaccines to Prevent COVID-19Investigational COVID-19 Convalescent PlasmaRevised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood ProductsDevelopment and Licensure of Vaccines to Prevent COVID-19Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency |
| CDER | FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health EmergencyCOVID-19: Developing Drugs and Biological Products for Treatment or PreventionPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the COVID-19 Public Health Emergency (COVID-19)COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 InfectivityAssessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or TreatmentInstitutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical InvestigatorsNotifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for IndustryCOVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or PreventionRemote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for IndustryCOVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for IndustryDevelopment of Monoclonal Antibody Products Targeting SARS-CoV- 2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency |
| CDRH | Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencySupplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyEnforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
| CFSAN | Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 PandemicTemporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID- 19 Public Health EmergencyTemporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency |
| CVM | CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency |
For each of the guidances in this category, once a revised final guidance is issued, it will supersede the current version of such guidance. FDA explains that the Agency could revise a guidance “so its duration aligns with an applicable declaration” that enables FDA to issue emergency use authorizations (EUAs) or “by removing language describing intended duration” altogether.
4. Guidances that are not tied to the expiration of the PHE declaration
FDA identifies the following four guidance documents whose duration is not tied to and will remain in effect after expiration of the COVID-19 PHE declaration.
| Lead Center | Title of Guidance |
| CDER | Product-Specific Guidances for Chloroquine and HydroxychloroquinePostmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
| CDRH | Policy for Coronavirus Disease-2019 Tests (Revised)Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests |
FDA recently revised the two above-listed guidance documents related to COVID-19 tests to state that their policies are intended to remain in effect for the duration of FDA’s declaration that allows for the issuance of EUAs for COVID-19 tests.
With respect to EUAs more generally, the Federal Register notice states that FDA intends to finalize “as soon as practicable” its December 2021 draft guidance regarding “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the COVID-19 Public Health Emergency.” For details of FDA’s proposed transition plan for these medical device EUAs, see our prior Alert discussing the details of FDA’s draft EUA transition guidance.
Last, FDA reserves the right to alter its approach for any of the individual guidance’s discussed above should circumstances change. FDA indicates that should the Agency alter its approach for a particular guidance, the Agency will do so consistent with its good guidance practices regulation, which generally allows for public comment prior to implementation, unless FDA determines that prior public participation is not feasible or appropriate.
[1] The PHE declaration was originally issued on January 31, 2020, and subsequently renewed by the Secretary of Health and Human Services (HHS) pursuant to the authority under Section 319 of the Public Health Service Act.
[2] The final version of the device enforcement policy guidance was transmitted to the Office of Information and Regulatory Affairs (OIRA) within the White House Office of Management and Budget (OMB) for review on March 10, 2023.
[3] The HHS Secretary declared on February 4, 2020, pursuant to the authority under Section 564 of the Federal Food, Drug, and Cosmetic Act, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of novel coronavirus (2019-nCoV).
[4] The final version of the transition plan for medical devices issued EUAs guidance was transmitted to the OIRA for review on March 10, 2023.