Device Lawyer: CMS Lab Crackdown Is Attempt To Rebuild Trust In LDTs

By Kelly Lienhard / October 13, 2020 at 3:45 PM
CMS announced that, since August, it has sent 171 cease-and-desist letters to labs that the agency says are not properly certified, a move that a medical device lawyer asserts could be an attempt by CMS to increase public trust in laboratory-developed tests in light of HHS’ controversial move to scrap FDA oversight of LDTs, including for COVID-19. CMS’ announcement comes three months after HHS declared that FDA will no longer require premarket review for LDTs , citing several of President...

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