Medical Device Regulation Act

By 1974, about 2.5 million women used this thing, and use of this device resulted in pelvic inflammatory disease, damage to the reproductive organs, sepsis, which is blood poisoning, infertility, sterility, miscarriage, and even death.

And this led to Congress passing the Medical Device Amendment, which now requires pre-market approval for medical devices, not just drugs now, but medical devices.

So far, we're talking about hardware.

The event that brought software into this picture was the Therac-25 accidents.