The district court decision on the FDA LDT case came out several weeks ago, with a flurry of rapid news and opinion.
Now that people have had time to reflect, on April 16, MedTechDive revisits the topic. Read a number of updated interviews with experts. Find it here:
https://www.medtechdive.com/news/lab-developed-tests-what-now-analysis/745464/
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Separately, see a deep dive subscription article by Adam Bonislawski at 360Dx, which is also an updated on FDA-LDT and new expert opinions.
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Re MedTech Dive - I'd mention two things -
- The FDA (the DOJ) has 60 days to file a "notice" of appeal.
- If they do that, it's just one sentence, and keeps the case alive for possible, further, later motions.
- So if the filing doesn't occur, the case is dead.
- BUT, if it DOES get filed, I wouldn't give that filing too much weight. It could be a bookmark in a book nobody picks up again.
- Let's give a little attention to what didn't happen - the FDA and HHS didn't make a peep of complaint about the decision.
- They could have, if they had wanted to. Just sayin'.
Separately - Rubrum Advising's Nancy Stade has a rather complex discussion of the LDT ruling and related regulatory law concepts - here. (See Stade's school of thought about "LDT" and with an asterisk - "LDT * " - which I don't fully understand.)
