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On the other hand, if you can submit a "new" medical device through the 510k process, it is the device manufacturer that certifies that the new equipment is equ
by seren 7y ago
On the other hand, if you can submit a "new" medical device through the 510k process, it is the device manufacturer that certifies that the new equipment is equivalent to an existing product. That is mostly comparable to what Boeing did.
- bilbo0s 7y agoYou can say that it is equivalent, but the FDA will still make you prove it with the relevant tests and documentation. And look, I'm not saying it's wrong that Boeing has it a lot easier than I did. I'm just asking what's the justification? In my case I get it. Imagine you're submitting a device that shoots high levels of radiation, at extremely high power, into the human body to kill cancer cells? Well yeah. I understand. The FDA doesn't care that you believe this device is the same as the last one. You're shooting high yield radiation... At levels fatal to humans... In the middle of a hospital... Which itself is potentially in the middle of a population center? OK, yeah, I get it. They're gonna check the new device as thoroughly as they checked the old one. No one wants the equivalent of a dirty bomb going off in some small town. I'm not complaining about that. I even understand that Boeing doesn't shoot radiation all over the place, so maybe things can be a bit more lenient? I get that maybe that was the justification? But here's the thing, Boeing can still kill people, as is plainly evident. Why is the government being so lax on them, while at the same time giving my RTP product the equivalent of a regulatory colonoscopy? I mean, if anything, both products should get the regulatory colonoscopy.