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FDA Roundup: October 7, 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 issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. 

“Today’s actions underscore the FDA’s ongoing commitment to expand access to monkeypox testing. continue to work collaboratively with test developers, labs and the CDC to encourage novel test development and facilitate access to safe and reliable tests that meet public health needs.” – Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

  • On Thursday, FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are pleased to announce their partnership with the Critical Path Institute (C-Path) to initiate planning for a consortium aimed at developing tools appropriate for use in clinical development programs for alpha-1 antitrypsin deficiency (AATD), a rare disease-causing progressive destruction of lung tissue leading to premature mortality or need for lung transplant.  

“FDA is partnering with C-Path to launch a pre-consortium collaboration aimed at addressing the need for clinical development tools in alpha-1 antitrypsin deficiency,” said Celia M. Witten, Ph.D., M.D., deputy director of FDA’s Center for Biologics Evaluation and Research. “There is a clearly demonstrated need for development of new treatments in this area and we believe that collaboration across stakeholders working toward this goal has the potential to help accelerate progress in the field.”

  • On Thursday, the FDA published the FDA Voices: “FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule,” by Hilary Marston, M.D., M.P.H., Chief Medical Officer and Ann Meeker-O’Connell, M.S., Director, Office of Clinical Policy. The agency published two proposed rules that demonstrate the significant progress we’ve made toward harmonizing our human subject protection regulations with the HHS Common Rule for the kinds of research the FDA oversees and consistent with our other statutory requirements. Supporting clinical trial modernization and protecting clinical trial participants will continue to be at the forefront of the FDA’s oversight of clinical research.
  • On Thursday, the FDA issued two final guidances that are intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These guidances are also intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and PAS requirements.  
  • On Thursday, the FDA provided updates from two postmarket studies for Essure—an additional year of follow-up data for Essure device removal and an interim study status for the FDA-required postmarket surveillance (“522″) study comparing outcomes for the Essure group and the tubal ligation group. Although Essure has not been available for implantation in the United States since December 2019, the FDA continues to monitor the product’s safety through an FDA-required postmarket surveillance study and other activities. The FDA remains committed to providing updates on our ongoing postmarket evaluation of Essure.
  • On Wednesday, the FDA published the FDA Voices: “FDA Outlines Work Underway to Ensure the Safety of Imported Produce,” by Donald Prater, Associate Commissioner for Imported Food Safety and Julie Moss, Director of the Office of International Engagement in the Center for Food Safety and Applied Nutrition. Recently, the agency released “Activities for the Safety of Imported Produce,” which outlines how the agency is working to enhance the safety of fresh fruits and vegetables through the four goals established in the 2019 import strategy. All food that reaches U.S. consumers must meet the same safety standards, including fresh fruits & fresh vegetables, which account for 55% and 32% of food imports respectively.
  • On Wednesday, the FDA added 178 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the U.S. by 510(k) clearance, granted De Novo request, or approved PMA. The Center for Devices and Radiological Health’s (CDRH) Digital Health Center of Excellence first posted this list in 2021. With this update, the FDA has also added the ability to download the list as an Excel file. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.
  • 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 1126 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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