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  5. FDA Roundup: September 27, 2022
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FDA News Release

FDA Roundup: September 27, 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 released its Activities to Enhance the Safety of Imported Produce, which provides an overview of the work underway to advance the safety of produce imported into the United States. This overview follows the 2019 release of the Strategy for the Safety of Imported Food (Import Strategy) that describes the agency’s comprehensive approach to enhancing the safety of food imported into the United States. 
  • On Monday, the FDA reopened the comment period for the request for information seeking available use and safety information on the remaining phthalates authorized for use as plasticizers in food contact applications. The new deadline for comments is Dec.  27, 2022. The FDA reopened the comment period in response to a request to provide stakeholders with more time to develop and submit data, other information, and comments for this request for information. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-0571.
  • On Monday, the FDA issued The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, a report authored by the Center for Devices and Radiological Health’s (CDRH) Digital Health Center of Excellence. In 2017, the FDA launched the Software Precertification (Pre-Cert) Pilot Program (“the pilot”) to explore the possibility for innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of their products once they reach the U.S. market. With this report, the FDA is marking the completion of the Pre-Cert Pilot Program. Based on the observations from the pilot discussed in this report, the FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change.
  • On Monday, the FDA announced that it is taking further action to help prevent outbreaks of foodborne illnesses associated with certain foods through the development of food safety prevention strategies. These prevention strategies are an affirmative, deliberate approach undertaken by the FDA and stakeholders to help limit or prevent future outbreaks.
  • On Wednesday, Sept. 28 from 12:05 to 1 p.m. ET, the FDA will host the next session of the virtual town hall series on test development and validation during public health emergencies. Topics will cover both SARS-CoV-2 (COVID-19) and monkeypox. No registration is required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. The future town hall events scheduled for October 5 and 12 will be on the topic of monkeypox only.
  • COVID-19 testing updates:
    • As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 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 1121 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.


 FDA Office of Media Affairs

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