[HeyLaughingBoy]

His characterization is not quite accurate. FDA does not certify it; rather, the company building the medical device certifies to the FDA that it has been properly validated for use and the FDA accepts their validation.

Trust in the company's ability to properly validate the device is tempered by regular FDA (and other regulatory bodies) audits of their development process and process data, test reports and a general desire to stay in business. FDA can and will take your product off the market if it appears to be unsafe and the company does not respond appropriately.

[x0x0]

Yeah, you have to create a testing/validation procedure and run the procedure with your hardware and software. So for human diagnostic devices, we had to purchase samples and basically show that we diagnosed to our prescribed accuracy levels. So there's a bunch of wetlab time/disposables involved.

Our machines were actually purchasable in two ways: one certified for human diagnostics (FDA Class III, I think), and one not, for eg veterinary or scientific use. The former got 1-2x/year software updates, while the latter got monthly releases. We had to enforce usage requirements both with contracts, download restrictions, and in-machine checking. ie you couldn't use the non-diagnostic firmware or software on a diagnostic-certified device. You also had to use certified reagents -- enforced in hardware -- in diagnostic devices.

It's a lot of work, but given some of the software I've seen, and the fact that if these machines get the diagnosis wrong you either won't be treated for deadly diseases or will be treated in very toxic ways for diseases you don't have, the requirements are reasonable.