FDA Roundup: April 15, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• On April 14, the FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19 Breathalyzer test is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The authorization for the InspectIR COVID-19 Breathalyzer test is an example of the FDA’s continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19. 

  The InspectIR COVID-19 Breathalyzer test: 

  • Is authorized to be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.
  • Is authorized to be performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes. 
  • Is for people ages 18 and older without symptoms or other epidemiological reasons to suspect COVID-19. 

  Positive test results should be confirmed with a molecular test. Negative results do not rule out SARS-CoV-2 infection. Health care providers should consider negative test results along with a patient’s recent exposures, history, and presence of other clinical signs and symptoms consistent with COVID-19 and should perform follow up testing if necessary for patient management.

• On April 13, the FDA announced that the new legislation clarifying the agency can regulate tobacco products containing nicotine from any source will take effect April 14, 2022. At this time, manufacturers, distributors, importers and retailers of products containing non-tobacco nicotine—that is, nicotine not made or derived from tobacco, such as synthetic nicotine—must ensure compliance with applicable requirements under the FD&C Act.
• On April 13, the FDA and the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response issued a statement that the shelf-life of bamlanivimab and/or etesevimab is being evaluated, and an update regarding shelf-life extension is planned for early May 2022. In the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.  

  Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. However, it is recommended that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States.

• On April 13, the FDA announced an upcoming virtual meeting about Augmented Reality (AR) and Virtual Reality (VR) Medical Devices. During this July 12-13 meeting, the Patient Engagement Advisory Committee (the Committee) will discuss and make recommendation on factors to consider when evaluating the benefits, risks, and uncertainty for AR/VR devices. The Committee will also discuss specific challenges related to vulnerable populations (for example, pediatric or cognitively impaired) who may use this technology.
• On April 13, the FDA issued a final guidance titled “Reconditioning Fish and Fishery Products by Segregation: Guidance for Industry,” which: 
  • Clarifies the steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine) or decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act.    
  • Recommends information that industry should include in reconditioning by segregation proposals. 
  • Provides uniform guidance and greater transparency to industry and stakeholders on how the FDA evaluates these proposals.
• On April 13, the FDA authorized a shelf-life extension for the two presentations of the Tris/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine, supplied in multiple dose vials with orange caps and labels with an orange border and in multiple dose vials with gray caps and labels with a gray border. The authorization allows the frozen vials to be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. This extension was granted following a thorough review of data submitted by the manufacturer.  A copy of the concurrence letter is posted on FDA’s website.
• COVID-19 testing updates:
  • As of today, 431 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 297 molecular tests and sample collection devices, 84 antibody and other immune response tests and 50 antigen tests. There are 77 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
  • The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 930 revisions to EUA authorizations.

     

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