In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023, the United States Food and Drug Administration (FDA) published a notice in the Federal Register on March 13, 2023, addressing the agency's various COVID-19-related guidance documents issued by all of the medical product centers. FDA's notice specifically discusses which COVID-19-related guidance documents will no longer be in effect after the expiration of the PHE on May 11, 2023, and which of those guidance documents FDA is revising to temporarily continue in effect. Since the start of the COVID-19 pandemic, FDA has issued more than 80 COVID-19-related guidance documents.
FDA identified 22 guidance documents that will discontinue immediately upon the expiration of the COVID-19 PHE on May 11, 2023. FDA concluded that the recommendations in such guidance documents are either offered in other guidance documents or stakeholders have resumed or adjusted operations and are no longer relying on the guidance documents based on the changing status of the COVID-19 pandemic. One example of a guidance document that will discontinue immediately upon the PHE expiration is Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency, which assisted drug and biological product manufacturers to plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the PHE to normal manufacturing operations while maintaining continuity of the drug supply.
FDA identified an additional 22 guidance documents that will be discontinued in connection with the expiration of the COVID-19 PHE deceleration after a 180-day wind-down period (or longer) to allow for an "orderly transition." On November 7, 2023, seven of the 22 guidance documents will no longer be in effect. One key guidance document that will discontinue 180 days after the expiration of the COVID-19 PHE is:
- Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals. This guidance announces the FDA's policy of enforcement discretion for certain drugs subject to REMS that require laboratory testing or imaging prior to prescribing by health care providers. The guidance specifically authorizes health care providers and/or dispensers to use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.
The subsequent 15 guidance documents which are covered under FDA's draft device enforcement policy transition guidance will not follow the 180-day transition period outlined in FDA's notice. Rather, the guidance documents covered under the draft enforcement policy will expire at the time set forth in the final device transition guidance, once issued by FDA. The following enforcement policy guidance documents are a few key guidances that will expire at a later date set forth in the final enforcement policy guidance:
- Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This guidance permits the distribution of computerized behavioral therapy devices (only those intended for psychiatric conditions) without premarket notification or compliance with other specific requirements. It also provides guidance on general wellness devices for COVID-19-related behavioral health for which FDA will not enforce the FD&C Act.
- 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. This guidance allows limited modifications to the indications, functionality, hardware and/or software of FDA-cleared noninvasive fetal and maternal monitoring devices that measure or detect fetal heart rate, maternal heart rate and/or uterine activity and that are used to support patient monitoring in a home setting.
FDA identified 24 guidance documents that they intend to retain with appropriate changes after the expiration of the COVID-19 PHE declaration. The 24 guidance documents will remain as is for 180 days after the COVID-19 PHE declaration expires. During that time, FDA plans to revise each of the 24 guidance documents. FDA notes that the revisions can include updating a guidance document's duration to align with an applicable declaration made under its emergency use authorization (EUA) authorities or removing the guidance document's intended duration altogether, making it permanent. Some key guidance documents that fall under this policy include:
- Emergency Use Authorization for Vaccines to Prevent COVID-19. This guidance provides an overview of FDA's recommendations regarding the data and information needed to support the issuance of an EUA for an investigational vaccine to prevent COVID-19, including chemistry, manufacturing and controls (CMC) information; nonclinical data and information; and clinical data and information, as well as administrative and regulatory information.
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. This guidance contains recommendations on the generation of data to support an EUA for monoclonal antibody products targeting SARS-CoV-2.
- Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised). This guidance allows for limited modifications to the indications, claims, functionality, or hardware or software of previously cleared devices in order to facilitate use in remote monitoring (e.g., moving from hospital to home environment) and/or facilitate use with COVID-19 patients. FDA does not intend to object to the changes being made without additional FDA clearance. However, any modification must not create "undue risk" to the patient. Additionally, this guidance further clarifies FDA's policy for clinical decision support software that are not considered regulated medical devices.
FDA identified four guidance documents that have supported FDA's COVID-19 response, but whose duration is not tied to the COVID-19 PHE declaration, and will remain in effect after the expiration of the COVID-19 PHE declaration. One key guidance document that will discontinue immediately upon the PHE expiration is the Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic. This guidance provides recommendations to the industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products and dietary supplements during any pandemic. This guidance revises a 2012 guidance to expand its scope beyond influenza viruses and to cover any pandemic.
Note that while FDA is discontinuing a number of policies due to HHS' decision to end the PHE, FDA's EUAs of diagnostics, therapeutics and devices are not impacted because they are authorized under separate statutory authority from the PHE declaration.
List of COVID-19 Guidance Documents Subject to FDA's March 13 Notice:
Guidance Documents Expiring With the Public Health Emergenc |
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Title |
Center |
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Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency |
CBER |
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COVID-19 Public Health Emergency Policy on COVID-19 Related Sanitation Tunnels |
CDER |
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Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic |
CDER |
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Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers |
CDER |
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Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency |
CDER |
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Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment is Needed During the COVID-19 Public Health Emergency Guidance for Industry |
CDER |
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Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency |
CDER |
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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing |
CDER |
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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency |
CDER |
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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and Answers |
CDER |
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Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
CDER |
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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 Guidance for Industry |
CDER |
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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 |
CDER |
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Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency |
CDER |
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COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products |
CDER |
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Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency |
CDER |
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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) |
CDRH |
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Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency |
CDRH |
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Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency |
CFSAN |
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Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency |
CFSAN |
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Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency |
CFSAN |
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Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency |
CFSAN |
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Guidance Documents Discontinuing 180 Days After the Expiration of the Public Health Emergency |
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Title |
Center |
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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 Industry |
CDER |
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Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers |
CDER |
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Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
CDER |
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Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency |
CFSAN |
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Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines |
CFSAN |
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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 |
CFSAN |
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CVM GFI #270—Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency |
CVM |
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Enforcement Policy Guidance Documents Continuing for 180 Days or Longer After the Expiration of the Public Health Emergency |
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Title |
Center |
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Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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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 |
CDRH |
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Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
CDRH |
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Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
CDRH |
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Guidance Documents FDA Will Revise Within 180 Days Following the Public Health Emergency |
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Title |
Center |
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Emergency Use Authorization for Vaccines to Prevent COVID-19 |
CBER |
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Investigational COVID-19 Convalescent Plasma |
CBER |
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Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products |
CBER |
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Development and Licensure of Vaccines to Prevent COVID-19 |
CBER |
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Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency |
CBER |
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FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency |
CDER |
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COVID-19: Developing Drugs and Biological Products for Treatment or Prevention |
CDER |
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Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the COVID-19 Public Health Emergency (COVID-19) |
CDER |
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COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV–2 Infectivity |
CDER |
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Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment |
CDER |
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Institutional 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 Investigators |
CDER |
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Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
CDER |
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COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention |
CDER |
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Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
CDER |
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COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry |
CDER |
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Development of Monoclonal Antibody Products Targeting SARS-CoV–2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency |
CDER |
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Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
CDRH |
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Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
CDRH |
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Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
CDRH |
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Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic |
CFSAN |
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Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency |
CFSAN |
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Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency |
CFSAN |
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CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency |
CVM |
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Guidance Documents That Will Remain in Effect Post-Public Health Emergency |
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Title |
Center |
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Product-Specific Guidances for Chloroquine and Hydroxychloroquine |
CDER |
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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
CDER |
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Policy for Coronavirus Disease-2019 Tests (Revised) |
CDRH |
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Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests |
CDRH |
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