I'm not really clear on why FDA is even involved with the biopsy? Maybe because they made a statement relating to the DBS device. FDA only has authority over cl

I'm not really clear on why FDA is even involved with the biopsy? Maybe because they made a statement relating to the DBS device. FDA only has authority over clinical trials. That means studies involving new devices or drugs (or new uses of them) that are intended to determine efficacy and safety. It's not obvious to me how these biopsies are related except through the association with modifications to DBS procedure and labeling that's intended for patient care. Having just read the tweet linked below (since I can't get past the paywall) this seems Health and Human Services ballpark. We can argue about whether FDA should have more oversight but there are very real restrictions on what FDA is actually authorized to do by Congress. That's all to say: FOIA into FDA is interesting but the IRB seems responsible here and there's a claim the researchers deviated from approved consent forms. Anyway it just seems that this might be complaining the FDA didn't do something that it cannot do.