FDA Announces the Discontinuation of Certain COVID-19-Related Guidance Documents

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.

To review each of the guidance documents that are covered by FDA’s March 13 notice, see the tables below. If you have any questions regarding any of the guidance documents or the status of a particular product, please contact Rachel Sher, partner, Manatt Health, at rsher@manatt.com or Matthew Itzkowitz, associate, Manatt Health, at mitzkowitz@manatt.com.

List of COVID-19 Guidance Documents Subject to FDA’s March 13 Notice: