In a fact sheet and a research report dated October 22, 2021, the Pew Charitable Trust argues that more federal oversight of LDTs is needed.
The authors conclude,
To ensure the public has access to safe, reliable, accurate, and innovative diagnostics, Congress should pass legislation that would increase the transparency of the market and authorize FDA to review them based on their risks to patients.
They note in a summary table:
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See a prior PEW Article, September 22, 2020, on need for risk based regulation of LDTs, here. See a PEW position piece, labs need stronger FDA oversight, January 11, 2021, here. See a PEW letter to HHS on April 28, 2021, here and here.
See an article, "Once a cheerleader for latest VALID Act, PEW now has some reservations," behind a subscription wall, at Medtech Insight, August 25, 2021, here.
See Medtech Insight behind the wall, "VALID Act Introduced for Third Time," 24 June, 2021, here. See a Medtech Insight article, open access for me today, "Abbott preps for potential VALID Act," Sept 28 2021, Here.
On a separate note, for a Pew Report on how FDA regulates AI, see here.