A webapp for creating calendar events with unique links to meet.jit.si for video conferencing. It was an early pandemic project that I haven’t done anything with since putting it up.
Thanks for this, which one specifically? My 5 year old watches cardboard project videos on YouTube and loves building. We even got him a hot glue gun which he uses on his own, after a couple of burns he’s very adept with it. Yes I tried to dissuade him but he’s very persistent!
We have a few of #2 we got from Amazon. You can still cut yourself but it's more of an abrasion than a laceration. It's great when you can find real tools for your kids to use and explore their ideas independently.
I have one of the #2's. It's certainly possible to cut yourself. I actually cut myself on purpose just to be sure it was safe, and it wasn't too bad ;-) It was an actual cut, not an abrasion, but not deep. I've gotten myself on accident a few times too. Never too badly.
He's got two weeks to provide the detailed information he should already have or a reason why he doesn't have it. He could even provide an estimate (see instruction #4 in the Special Order). The threat of legal consequences is if any information/reason is missing or if the order is completely ignored. Getting your company shut down by the government only comes after a lot of back and forth communication and is usually due to willful negligence on the company's part.
Why do that when you could just get the information directly from the NHTSA [1]? I expect all those companies have been in communication with regulators from the beginning and produced plenty of documentation. Besides, they can't do the same thing the large players did since they aren't in control of developing the entire vehicle.
I read a bit of that, and it looks like the document you linked does not support the threat to fine $21k/day for not responding to the Special Order.
There is quite a lot of "voluntary" in there, along with "future regulation". I would guess that a lot of the voluntary safety assessment letters they get essentially say, "this is not entirely safe in absolute terms, but is definitely safer than an inattentive human driver."
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
We had downloaded several 510(k)s early in our process, but found them so heavily redacted that they didn't really give the overview we needed. That's why we worked so hard to redact as little as possible in our own docs. I'll dig deeper into that set of links to see if there are some that have more info in them. Thanks!
First of all, thank you Shift Labs for putting up their information and helping make confusing regulatory processes clearer.
Secondly, I want to let people know my company[1] works with many start-ups in the medical device space that are developing regulated products, both 510(k) and CE mark. We are engineers that understand the regulatory process not just regulatory consultants.
If anyone is interested feel free to contact me akehrer@in2being.com.
If Mr. Gustavsson is involved I wonder why there's no mention of the regulations they need to pass before they can sell units in the US. I did a quick search [1] and found a few of the systems he has been involved in and they are all FDA Class II devices which is a long, involved process. They'll need data showing substantial equivalence to a predicate, unless they've come up with a way to get around the FDA. At a minimum they'll have to register as a laser product with CDRH before they can ship anything. [2]
Perhaps that is why they are going through Kickstarter... to get at the "dumb money" -- meaning that they want investment from people who arent going to ask about imperial entanglements regarding class II devices...
They want to get the thing made and out the door before scrutiny from FDA types would cost them more money than the actual product dev.
It's great that the tools and services the article mentions are out there but I think the author misses the wide gulf there is between limits of what can be done in a garage or shared lab and the resources, time and capital to do things like synthetic biology and drug discovery.
It would be interesting to see where the DIY biotech movement could apply the biotech research tools and methods to where people are already doing home "biohacking". Could home brewers and fermenters gain insight into what's going on inside their jars? Maybe small scale farmers would be interested in quantifying the bacteria in their soil. Larger brewers are already using PCR to check for spoilers in their beer, could this be turned in to BaaS (Biology as a Service) and expanded, or trickled down to the home brewer?
BaaS, hah! The rest of the world calls 'em CROs :)
In theory, one could develop a CRO for DIY biologists, but I just wonder how many of them there actually are. We've made comments downpage about releasing biology to the masses like Jobs and Gates did with their PCs and operating systems...but it really feels like something is missing. The passion of the Homebrew Computing Club? The public's aversion to science, or maybe its short attention span for failed experiments?
Yeah, BaaS :-), but what CRO would take on those type of jobs when they can't charge what they do for clinical trials or drug discovery.
I'm not sure how much interest there is either and I agree that something is missing. Maybe affordable kits similar to how PCs became more accessible to the masses as IC prices came down. Maybe bringing modern scientific equipment in to school biology classes to expand public knowledge beyond test tubes and bunsen burners.
A webapp for creating calendar events with unique links to meet.jit.si for video conferencing. It was an early pandemic project that I haven’t done anything with since putting it up.