This @HHSGov memo posted by @politico gives the lab industry adminsitrative legal cover to deflect FDA premarket review. But once lab tests enter the market, the memo discusses a legal path @US_FDA can use to remove bad actors. politico.com/f/?id=00000174… @davidalim
Look, even in its statement in August, @HHSGov said @US_FDA will not require premarket review of lab tests. It didn't say anything about all other levers the agency can use to rein in bad actors...including post-market actions. hhs.gov/coronavirus/te…
The few times FDA has taken actions against LDTs it has been against lab tests already being marketed (so technically not a premarket action). 360dx.com/regulatory-new…
The arguments in the @HHSGov statement and memo are not new. Lab industry has been making them for years. 360dx.com/molecular-diag…
Now the lab industry has the legal arguments of the Trump Admin to back them up should new admin want to abruptly reverse course. But does it change anything in terms of how labs have been operating all along? Or increase public health risk?
Memo does force a change in how FDA talks publicly about its authority over LDTs. If the @US_FDA now wanted to impose premarket oversight on LDTs, I don't see a path other than via legislation. There are two bills currently #VALID and #VITAL 360dx.com/molecular-diag…
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