FDA After RUO collection devices used in LDTs; RUO Device is not LDT

 Going back decades (23andMe), FDA has honed in on "collection devices" to undercut venders of LDTs.  Generally, the collection devices are at one point labeled RUO, but at another point, sold with patient care instructions.

There were several examples circa 1-1-2016.   There are other examples in the past at regular intervals.

Here are a couple examples:

See this letter AGENA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agena-bioscience-inc-665159-03212024 

See this letter to DRG, a Euro company

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/drg-instruments-gmbh-700918-03312025