Comment by spartango

My experience in the space is that this is a mischaracterization of the FDA, but also misses an important point:

Theranos does not fall under the FDA's mandate in its current form. It is a CLIA-certified laboratory operation, regulated under CDC rules and scrutinized most likely by the College of American Pathologists(CAP). The CLIA/CAP scrutiny is very different from the FDA device/drug process, focusing on protocol and output. Even if they have novel technology, it is often classified as a laboratory developed test(LDT) and falls outside of the FDA's mandate (for now).

Many startups have achieved CLIA-certification without too much difficulty, from Foundation Medicine to Veracyte to Counsyl. It's totally reasonable and doesn't take too long.