Comment by nomel
1 day ago
What standard exactly, for a stethoscope?
I know nothing of this, but it looks like stethoscopes are Class 1 medical devices with 501(k) exemption, and fall under the "Good manufacturing practices" guidelines of Quality System Regulation (21 CFR 820), but that seems pretty squishy.
CFR 21 being labeled squishy is a first for me.
CFR 21 is the whole thing. I'm specifically referring to Part 820, within the context of a stethoscope.
Fair