Has anyone seen anything from FDA about the collection and use of clinical data on EUA products?
There is a guidance on the investigational use of of convalescent plasma, but I haven't seen anything on the investigational use of products that have EUAs.
There is a guidance on the conduct of clinical trials during COVID-19, but its focus seems to be on trials of other products that may be disrupted or delayed by the epidemic.
It appears that patients are being informed that these products are not FDA approved, but I don't think any type of consent is required.
At this point, I'm thinking that any clinical data obtained from the clinical use of an EUA product cannot be used to support a claim of safety or effectiveness unless the data are collected under an IDE. I think this could include a retrospective study conducted under an abbreviated IDE, capturing only data that were generated in the course of clinical treatment.
Anyone know of anything FDA has issued that says otherwise?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------