A Call for LDT Regulation

New York Times Editorial asks FDA to release plans for tackling lab-developed tests.

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Laboratories that offer the

Laboratories that offer the LDTs bear liability for performance of the substandard test and issuing data that are not substantiated by validation I don't think additional regulation by FDA is needed here.

Liability does put the fire

Liability does put the fire up the backside of those who use LDTs but it also thé way to go about it backwards. Regulations is established by means of a Quality Management System.
A QMS has the patient in mind.
Avoidance of liability has the company in mind.

Liability merely means that when worst come to worst, the one with the best lawyer wins. That's not the safety that the weakest have a right to expect, that's a free for all and the biggest wallet will surive.
Besides if you don't want regulation and rules, don't use the liability system because the bureaucracy from the legal department will be many times that of a QMS, with the difference that a QMS is truly is meant to protect both the patient AND the company.