Coronavirus (COVID-19) Update: Daily Roundup June 22, 2020

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/effects-covid-19-public-health-emergency-formal-meetings-and-user-fee-applications-medical-devices?utm_campaign=062220_PR_Coronavirus%20%28COVID-19%29%20Update%3A%20Daily%20Roundup%20June%2022%2C%202020&utm_medium=email&utm_source=Eloqua

Coronavirus (COVID-19) Update: Daily Roundup June 22, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued a guidance document, titled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers,” with answers to frequently asked questions. These include answers concerning certain aspects of sponsor requests for formal meetings with the FDA, user-fee application goals and timelines, and other regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.  As part of the FDA’s continuing effort to protect consumers, the agency issued a warning letter to one firm for selling fraudulent COVID-19 products. The seller, North Isle Wellness Center, offers Methylene Blue products for sale in the United States with misleading claims that the products can mitigate, prevent, treat, , or cure COVID-19 in people. The letter requests that the seller take immediate action to cease the sale of such unapproved and unauthorized products. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Testing updates: To date, the FDA has authorized 145 tests under EUAs; these include 122 molecular tests, 22 antibody tests, and 1 antigen test.