> if you want to say that "I can think whatever I want, I just can't act on it"

As I specifically pointed out, you can act on it. You can make any medical device, or engage in any medical practice, for and to yourself. You just can't sell or distribute it to others.

Yeah. But judging by his profile, ibeckermayer explicitly wants to build insulin pumps and sell/distribute them without having to go through FDA approval. So for him it comes down to "I can't act on it in the way I want to", namely, distribution.

I'm with you in the camp that says that it's good that he cannot do that.

How do you know this is a good thing? Say I were to start a company that makes an exact replica of the devices talked about in this article, with a built in Loop system? Is it "good" that I can't do that. Is it "good" that people are forced to scrounge for discontinued remnants of un-secured devices, and then forced to hack together this system themselves just to get it cheaply?

Maybe you do think that's "good", but that begs the question of whether its "good" to force people to agree with you. If you want to use exclusively FDA-approved devices that's your right, but what about the many people who need insulin who disagree? Is it not true that they should be free to conclude for themselves?

Yes, I think it that it's good that you have to prove the effectiveness of a device that can injure or kill people if it fails, before you're allowed to try to sell it. Yes, I'm very skeptical of someone who wants to just pinkie promise that they really did adequate due diligence, and that we should trust them. I'm very skeptical of the idea that manufacturers should be able to claim what they want and let the customers/patients decide for themselves.

Is it good to use force to stop people from doing otherwise? Yes, I think it is. Otherwise you have people cutting corners (or just outright lying), selling devices that don't work, that fail, that kill people, and then, after the fact, the company gets a bad reputation and people stop buying from them. The people who died are still dead, though. Is that a "good" outcome?

Look. You want to make this stuff. Fine. Go make it. Then get it FDA approved, and sell it. Because the fact is that all your whining isn't going to change the FDA or the law. I think the current system is good, you think it's not, but if you want to actually do something, it's the system you're going to have to work within. You say these people need these devices? Go make them within the system that exists. Or are you going to do nothing but complain? That doesn't help any of the people you claim to feel such sympathy for.

> How do you know this is a good thing?

I know this is a good thing because I'm aware of what happens when there is no regulation of medical devices and medications. The FDA was created for a very good reason. Just take a look at what was going on that led to its creation.

When left unregulated, innocent people get mutilated and/or die . It's as simple as that.

Now, I think that there is room to argue that the regulation can be done better, but I strongly disagree with the idea that there should be no, or optional, regulation.