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Looks super cool! > It still needs to obtain the necessary medical certifications in order to sell its glasses and get all the production pieces in place Oh,
by xp84 5mo ago
Looks super cool!
> It still needs to obtain the necessary medical certifications in order to sell its glasses and get all the production pieces in place
Oh, ok. I hope they have enough funding to last till the FDA clears them, in 2030 :/
The same organization which allows any snake oil to be marketed as long as they say it’s a “supplement” will hold a pair of glasses up for years, as though there could be a hidden danger to a lens that can change to a second prescription.
- dcrazy 5mo agoThe FDA doesn’t “allow” snake-oil supplements. They have no authority over supplements.
- SoftTalker 5mo agoThey in fact do have a lot of requirements for supplements and their labeling, but do not require (in fact forbid) any claims that the supplements should be used to treat or cure any disease. https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide https://www.fda.gov/food/dietary-supplements-guidance-docume...
- snackbroken 5mo agoThere is potential danger with a lens that can suddenly change to a second prescription. For example: imagine you're driving and your whole field of vision suddenly starts flickering in and out of focus. That would be incredibly distracting and pretty dangerous. Even if they just started focusing on 1 foot away it'd be quite bad.
- Nifty3929 5mo agoThese glasses address farsightedness, which doesn't apply while driving. Worst case you just take them off.
- cperciva 5mo agoPlenty of us are simultaneously far and near sighted. I can't drive without glasses, but until I got progressive lenses I couldn't use my phone with my glasses on.
- WalterBright 5mo agoIf you cannot drive without glasses, the sensible thing is to keep a backup pair in the car. After all, glasses can fall off and get lost under the seat, get stepped on, etc.
- t-3 5mo agoThis is why I keep a pair of prescription sunglasses in my car. Added bonus is cutting the astigmatism glare while driving at night.
- Noumenon72 5mo agoThat's a smart idea, similar to how I keep a little cash in the car just in case. For example, I could get something in my eyes and have to remove my contacts, and an old pair of glasses would let me get home.
- gchamonlive 5mo agoStill doesn't address the fact that if the glasses fail mid drive it poses a serious security risk if you can't pull over to switch glasses. Doing so in a highway in a moving car is inadvisable regardless of the technology behind the glasses.
- WalterBright 5mo agoKeep them within easy reach, like the driver door pocket.
- gchamonlive 5mo agoChanging glasses while driving on a high speed lane is dangerous regardless of where you put your spare glasses
- onemoresoop 5mo agoAdd warning not to drive with them. Problem solved.
- DoctorOetker 5mo agoIf it worked 99% of the time, compliance would be nil, but you don't want these drivers to be affected 1% of their commute Even if a person would be compliant, if they wore this most of the time, they wouldn't be accustomed to the varifocal lenses while driving, guaranteeing that whatever other solution than these autofocusing lenses they select for driving, they won't be adapted to them whenever they drive.
- deleted 5mo ago[deleted]
- WalterBright 5mo agoThe FDA needs to make the glasses as expensive as possible.
- kelnos 5mo agoI don't think the FDA should be regulating based on whether or not it's safe to drive while using something. There are plenty of FDA-approved drugs that should not be taken while operating a motor vehicle.
- therealpygon 5mo agoAre those drugs required for driving by the people who use them? I would expect if so, they would be tested more thoroughly before putting people on the road with a new drug, much like I’d rather not have someone driving toward me at a combined opposing speed of 100-120mph, two feet apart, while relying on “we didn’t think it will be a problem but we didn’t bother to test”. That said, there is certainly room for an improvement in funding so that the FDA could go through processes more efficiently, but “efficiency” is rarely ever achieved by cost cutting because it confuses cause with effect.
- jurgenburgen 5mo agoOr they could just ban using these glasses while driving. There’s plenty of people who don’t actually need to drive who would buy this.
- BigGreenJorts 5mo agoI think enforcement would be poor and therefore abuse would be high, but it could be granted that they're not safe for driving and therefore if you own a pair, you must switch to different (your old regular dual focus lenses) when driving.
- jurgenburgen 5mo agoEqually hard to enforce as people driving without their normal prescription glasses. In both cases enforcement is reactive and happens after an accident has already happened.
- xp84 5mo ago> For example: imagine you're driving and your whole field of vision suddenly starts flickering in and out of focus Imagine you're driving with regular glasses and one tiny screw gives way and they fall off. Imagine you rub your eyes and your contact falls out. Those can't be 100% ruled out either. But anyway, the FDA imposing a half decade of delays on this will do zero to prevent that from happening. The article says when unpowered they revert to being regular glasses for the main prescription. So the main reason they could glitch out like you suggest would be a software bug. After approval, a future software update could still introduce that bug anyway. So either the FDA has to find a way to review every software patch with perfect bug-detection abilities, or they are useless here and just wasting our money pretending to regulate things without adding any value. Note that I'm not saying they have no role -- though I would say they do seem to be the worst in the first world at their actually needed job of balancing risk and access in the 'actual medications' department.
- NDlurker 5mo agoYou should look into dietary supplement regulations, specifically about label claims and advertising.
- xp84 5mo agoYou mean the rule that’s basically “Anything goes” as long as you reproduce the magic incantation in tiny print at the end: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
- NDlurker 5mo agoThat's not how it works.
- kelnos 5mo agoThen perhaps tell us how it works, rather than just being negative toward other people's comments.
- NDlurker 5mo agoThat user could have googled it instead of making a false claim. https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide https://www.fda.gov/food/dietary-supplements-guidance-docume... https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-C/section-101.36 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B... https://ods.od.nih.gov/About/DSHEA_Wording.aspx https://ods.od.nih.gov/About/DSHEA_Wording.aspx
- dimes 5mo agoLinking to a huge list of supplement guidelines, most of which cover labeling of nutrient content is not helpful. I did try to dig in, however, and found this: > A qualified health claim is supported by less scientific evidence than an authorized health claim. FDA requires that qualified claims be accompanied by a disclaimer that explains the level of the scientific evidence supporting the relationship. > Unlike authorized health claims, FDA does not issue regulations for qualified health claims. That does seem to indicate supplement manufacturers have broad latitude to make claims provided they are disclosed as such.
- stubish 5mo agoFDA certification would only be needed to ensure US insurance companies foot some of the bill, surely? It would mean a larger market, but the USA isn't the only market for prescription lenses.