Pharmaceuticals and medical devices have life and death implications. But prohibiting a life-saving product is just as deadly as allowing an unsafe one, and there are existing mechanisms that punish the sellers of dangerous products (it comes out and they lose their customers and get sued).

This comes from a facet of human psychology: If you do something and people die then you're a murderer, but if you do nothing and people die you're allowed to shrug and go home. This may be a reasonable heuristic when deciding whether you should do something but it isn't when deciding whether to prevent someone else from doing something.

The problem is that some medical devices are approved despite their being demonstrably deadly as they are designed, manufactured, shipped, and used without sufficient oversight by the governing body of apologists put in place to oversee them. This pattern has only worsened since therac 25.

I didn't make a judgement, was just pointing out the slippery slope of your argument. If you place someone in charge of allowing things to come to market, particularly those in the role of safety, their safest option will always be to say no.