Julie Omohundro Yes, Theranos rolled out its test as an LDT. CLIA doesn't approve tests; it certifies clinical labs. According to FDA's withdrawn LDT guidance, an LDT must be conducted in a CLIA-certified lab.

Eyal Lerner, Ph.D., B.Pharm, ICQE Thanks, you Julie.
This might explain the often-asked question on how did "Theranos" got under the FDA's RADAR for so long time. I am concern that some other MD IVD companies might took advantage on this path to enter the market with devices that otherwise wouldn’t been approved or at least were request first to provide additional information like on the design controls before granting FDA's marketing approval.

Eyal Lerner, Ph.D., B.Pharm, ICQE Thanks Julie. This might explain the often-asked crucial question on how did "Theranos" got UNDER the FDA's RADAR for so long time?
I am concern that some other MD companies might took advantage on this path to enter the market with devices that otherwise wouldn’t been approved or at least requested to provide additional information like on the design control, for instance.

Julie Omohundro Actually, what I want to know is how did if finally get ON the radar. It may have been because it opened up a lab in AZ, crossing state lines and also violating FDA's requirement (that I don't think it really had in place until after Theranos) that LDTs be used only in the lab in which they were developed. A popular theory (quite possibly true) is that one or more of the big IVD companies snitched. Sometimes the competition is a better watchdog than FDA, as it has almost no resources for surveying the environment outside of its standard radar.

Julie Omohundro There are apparently many clinical laboratories using their own "home brew" tests on patients, rather than purchasing FDA-cleared or -approved commercial kits. No one knows how many. Like the Theranos lab, they are CLIA certified, but their home brews are not approved by anybody, except indirectly, in that they are "approved" by FDA because they meet FDA's (withdrawn) definition of an LDT.

Julie Omohundro It's my position that LDTs are not products. The labs don't sell them to themselves. They offer a service, and they use tools they have developed to deliver the service. FDA is charged with regulating products, not services. Therein lies the rub, IMO.

Julie Omohundro The equivalent "back door" for traditional medical devices is Class I, 510(k)-exempt (similar to "self-certification" available in the EU), which allows very low-risk devices to enter the market without prior regulatory review. Of course it's the manufacturer that decides if its device belongs in this classification.

However, FDA does have something of a safety net for these devices. The manufacturer still has to register and list its device with FDA, which puts it on at least the fringes of FDA's radar, and is still obligated to report serious adverse events. The latter serves as a way of alerting FDA that it might not be a very low-risk device after all.

Pragmatically, FDA doesn't have the resources to do much more than this, nor is it ever likely to. So, fingers crossed...