It still kills me that they let Boeing 'self-certify' their own airplanes.
I had a diagnostic medical imaging startup. You can't even imagine the pain the FDA inflicted on our bottom line before they would give an OK on anything. But the FAA is out there just taking the word of some company's engineers that "Yeah. We're good."?
I guess I just thought that all of the regulation, was like it was in the healthcare field. Guess not.
Unfathomable for me either and reeking of utter corruption.
I could ALMOST understand it if they would do it in the medical field because there are so many companies small and large working in the field. But no, the FDA is indeed stringent and thorough.
But airplane manufacturing in the US? Hello? How many aircraft do they have to verify? It's not like there's 100s of manufacturers releasing 100s of plane designs.
The 787 and 737max were the only ones released in the last decade. And both were partly self-certified!
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.
You 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.
You appear to me making a mistake thinking your particular experience with your medical imaging device is normal. A lot of very dodgy medical devices such as cobalt hips and fallopian tube implants and surgical meshes have been approved with terrible oversight from the FDA causing unbelievable harm to people. The FDA is definitely far too lax (maybe fairer to say captured by industry) in a lot of areas they are supposed to regulate.
