4 ms·
Agreed. Class III hardware is well controlled (i.e., implants), but software (any class) and lower-class hardware is loco. My device was Class II.
by SentinelLdnma 4y ago
Agreed. Class III hardware is well controlled (i.e., implants), but software (any class) and lower-class hardware is loco. My device was Class II.
- seehafer 4y agoThis change would have certainly increased overall risk so a new 510(k) would have been required if this device was already commercialized. And had your management not backed down, and tried to push this through as a Letter to File, you'd have been well-within your rights to blow the whistle to FDA. There's not a FDA employee alive that wouldn't go "hold on there chief" to a device change of this magnitude.