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This occurred before the device was submitted for its first 510(k) approval.

Also, companies have some discretion in what changes they re-submit to the FDA and what the decide to just document internally. There are guidelines, like if you change the OS you better resubmit, but there is a wide swath of gray area. The FDA is not looking at every code/hardware change request. They audit your process.

Edit: typos

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Yeah, I'm on the small molecule side but did a combo device years ago and was shocked at how slack the device rules were compared to the drug side.

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.

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.

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