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Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results
by smackfu 13y ago
Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
- Dylan16807 13y agoThere is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
- smackfu 13y agoTo be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.