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May 08, 2020

Health Law Daily

FDA Releases New Guidelines For Developing, Marketing At-Home Coronavirus Diagnostic Tests

  • May 08, 2020

The New York Times (5/7, Jacobs) reports the FDA “has posted new guidelines that could pave the way for millions of people to test themselves for the coronavirus at home.” The guidelines “allow companies to develop and market testing kits with the tools to swab their noses and mail the specimens to any lab in the country.” The agency “said it hoped the new guidelines, posted on its site on Wednesday evening, would greatly boost the availability of tests by encouraging manufacturers to mass-produce at-home collection kits.” Experts not involved in the guidelines “said they were optimistic about the prospects for home testing, but questioned whether the country’s commercial labs could process a deluge of self-collected samples.”