Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) clarifies and enhances FDA’s authority to foster the development and availability of medical products for use in domestic emergencies involving infectious disease threats.
On May 11, 2023, the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act expired.
Since the start of the COVID-19 PHE, the FDA has been committed to providing timely recommendations and regulatory information to support response efforts, and important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. The FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition.
Importantly, the ending of the PHE declared by HHS under the PHS Act will not impact FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.
PAHPRA authorizes the emergency use of an unapproved medical product or an unapproved use of an approved medical product to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a chemical, biological, radiological, and nuclear (CBRN) agent, when there are no adequate, approved, and available alternatives, after the United States Secretary of Health and Human Services (HHS) Secretary has made a declaration of emergency or threat justifying emergency use.
On the basis of this determination, the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and or diagnosis of COVID-19, personal respiratory protective devices, and other medical devices, including alternative products used as medical devices.
Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices related to COVID-19 are currently:
Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices related to COVID-19 are currently:
- Blood Purification Devices EUAs
- Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
- In Vitro Diagnostics EUAs
- Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
- Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under Clinical Laboratory Improvement Amendments (CLIA) To Perform High Complexity Tests
- Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
- Individual EUAs for Serology Tests for SARS-CoV-2
- Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
- Individual EUAs for IVDs for Management of COVID-19 Patients
- Decontamination Systems for Personal Protective Equipment EUAs
- Infusion Pump EUAs
- Personal Protective Equipment EUAs
- N95 and Other Respirators EUAs (including EUAs for NISOH-approved N95s and imported respirators)
- Umbrella EUA for Non-National Institute for Occupational Safety and Health (NIOSH)-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China
- Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
- Face Shields and Other Barrier EUAs
- Remote or Wearable Patient Monitoring Devices EUAs
- Respiratory Assist Devices EUAs
- Ventilators and Ventilator Accessories EUAs
- Other Medical Device EUAs
On May 17, 2022, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years.
GlaxoSmithKline LLC’s Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. Effective April 5, 2022, health care providers should use other approved or authorized products as they choose appropriate treatment options for patients. FDA will continue to monitor BA.2 in all U.S. regions and will provide follow-up communication when appropriate.
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
FDA recommends that a request for an EUA include a well-organized summary of the available scientific evidence regarding the product’s safety and effectiveness, risks (including an adverse event profile) and benefits, and any available, approved alternatives to the product.