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.
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.
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.
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):
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 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]
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.
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?
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.