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  5. FDA Roundup: October 4, 2022
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FDA News Release

FDA Roundup: October 4, 2022

For Immediate Release:

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

  • Today, the FDA posted a Constituent Update, highlighting that in September, the FDA and CDC signed a MOU to strengthen food safety in retail environments. The goal of the renewed partnership between the FDA and the CDC is to help reduce the occurrence of foodborne illness in retail and foodservice establishments.
  • On Monday the FDA issued a Safety Alert to warn consumers about raw Canadian oysters potentially contaminated with salmonella. 
  • On Monday, the FDA announced that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal (“CDRH Portal”).
  • “This announcement is a significant step forward in the FDA’s commitment to digital transformation to increase efficiency, transparency, and simplicity for medical device premarket submissions. While the FDA’s broader modernization efforts began in September 2019, the COVID-19 public health emergency and ongoing industry input sharpened our focus on transforming technology and processes to better serve all stakeholders. With the CDRH Portal, manufacturers of devices can now quickly upload eSTAR and eCopy submissions for several submission types and continue to track the progress of 510(k) submissions on a secure website. CDRH intends to expand its tracking feature to other submission types and add other capabilities in 2023.” — Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. 
    • Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.
    • Starting October 1, 2023, all 510(k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions), must be submitted as electronic submissions using eSTAR.
  • On Monday, the FDA released important information about the risk of COVID-19 due to certain variants not neutralized by Evusheld (tixagevimab co-packaged with cilgavimab). Health care providers should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.   
    • Evusheld is currently the only option for pre-exposure prophylaxis (PrEP) of COVID-19. The FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants. 
    • Detailed neutralization data can be found in the revised authorized Fact Sheet for Healthcare Providers.
  • Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on October 13, 2022, from 12:00 to 1:00 p.m. EDT, on the topic, “Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins.”
  • COVID-19 testing updates:
    • As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1125 revisions to EUA authorizations

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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