FDA Revises Two Guidances to Extend Enforcement Discretion Policies

Public health emergency response and other updates from FDA since our last MCMi email include:

• July 13, 2023: FDA re-issues two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).
• July 13, 2023: FDA and the U.S. Department of Agriculture and the Department of Homeland Security make available the 120 Day Food and Agriculture Interim Risk Review, which provides a review of critical and emergent risks to the U.S. Food and Agriculture sector, as well as ways to mitigate those risks.
• July 11, 2023: FDA Roundup including FDA’s Center for Veterinary Medicine (CVM) detailing how it is working to stop illicit xylazine from entering the United States. 
• July 07, 2023: FDA Roundup including the FDA, Office of the Chief Scientist, Office of Regulatory Science & Innovation announcement of several renewal awards and one new award for the Centers of Excellence in Regulatory Science & Innovation (CERSI) Program.

• FDA is re-issuing two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).
• Although the PHE ended in the United States on May 11, 2023, the FDA recognizes that certain international firms might still be impacted by COVID-19 travel restrictions and advisories.
• Therefore, the FDA has revised the two guidances to extend the enforcement discretion policies issued during the PHE relative to supplier onsite audits for the FSMA Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs rule, and onsite monitoring activities and duration of already-issued certifications for the Accredited Third-Party Certification Program (TPP), when certain circumstances are met.
• The enforcement discretion policies described in the revised guidances Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 and Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19, remain unchanged. The FDA anticipates that when the guidances are no longer needed, the FDA will publicly announce the withdrawal of the guidances. 

EUA revocations

FDA revoked the following EUA for the reasons noted in the revocation letter (PDFs): 

• July 07, 2023: CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

EUA quick links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Expiration date extension

Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. 

Quick COVID-19 resources

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.