[HeyLaughingBoy]

This seems similar to what we do in medical devices.

The manufacturer creates a set of procedures covering the design process that meets, at a minimum, the stages set out in 21CFR, often following the industry standard for software: IEC-62304. Then mfr documents that those procedures were followed and at the end submits a set of documents about the test results and development process for agency approval.

Sound similar? One difference I can see is that if you replace the software in a released medical device with your own, it's no longer considered to be Approved and using it opens you up to Federal liability.

[AlotOfReading]

There's some similarities with the FDA, but quite a lot of important differences. NHTSA doesn't approve vehicles, for example. Manufacturers can sell whatever they want. NHTSA simply has the power to issue recalls (preventing further sales) if those vehicles don't comply with FMVSS.

NHTSA also doesn't incorporate standards like the FDA does, so while they're aware of industry standards and employ a number of relevant experts for various purposes, you're under no obligation to follow them. Tesla is actually an example here. Their development processes don't follow ISO-26262 (the automotive equivalent of IEC-62304), though stating this properly would need a lot of asterisks I don't want to get into.

The EU does both of these things for vehicles, though it's a bit more complicated than a flat approval or rejection and it's handled by a designated third party that also does medical device testing like TÜV SÜD. Other countries like the UK have a dedicated agency to handle type approvals.

[thaeli]

Emissions related components work very similarly, replace the software and it’s presumed to be a defeat device unless proved otherwise.