This 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.
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.