It's kinda crazy hearing Apple mention during their event that they expect FDA approval "very soon", and it actually happening 3 days later. I would have thought that governments can't promise timelines to anyone, especially something like FDA approval.
The event was prerecorded. It doesn’t seem farfetched¹ to think they already had the approval but legally couldn’t say it without the FDA making it officially public. But if the FDA had announced it before the event, it would’ve stolen the surprise. Not only of the feature, but that new AirPods would be announced. Apple would’ve hated that so they may have asked for the announcement to be delayed.
¹ Maybe it is. I’m not an expert on the USA’s health and government policies.
The approval process requires steps on both sides; Apple could've just delayed sending the last bit of finalising paperwork until they were sure it would drop after the announcement.
apple actually didn't release any 'pro' airpods at this event, the feature is for the pro 2's which have been out for over two years now, was glad it wasn't made a feature only for a new version
I don't think they can promise. But in a formal process with so many steps involved, you know what else is left to be done. And if there's nothing left, you assume "very soon" completion.
Also Apple's announcement was kind of a pressure put on the gov: "hey, enough, unless you want everyone angry at you".
The government is not telling you which headphones you can wear. They are saying that these particular headphones work well enough as a hearing aid that it is ok that market them as such. This protects you from quacks that claim their device is a hearing aid but that doesn’t actually work.
To be fair, in the case of hearing aids you are both in the right.
Excessive regulation has created oligopolies and kept prices high in the US. The OTC hearing aid category is meant to help. Before that, low-cost devices tended to remain niche.
OTOH the regulation(s) were introduced due to blatant sales of substandard devices, esp in the 1970s. A high-amplification device runs the risk of further damaging your hearing. Many hearing aid users are vulnerable elderly.
Nobody is telling anyone what kind of headphones they're allowed to wear. They do, however, tell _companies_ that they can't claim their product has medical benefits without proving (to some kind of standard) that the product is safe to use, and does what it claims to do. This system was put in place after businesses spent decades scamming the public with "medicine" that didn't do what it claimed to do and, in many cases, was also poisonous.
If you've submitted a 510k for your medical device, you can advertise it as "510k pending".
There is a risk that you never receive the clearance or approval, but in this case Apple probably knew they had already addressed any feedback the FDA had so it was very likely there would be no further stumbling blocks
What in Apple's statement made you think the FDA promised them anything? They were probably all the way through with everything they needed to do for the FDA process and, well, there's a timeline for this process so that's why they knew.
510ks have a 90 day timeline. The FDA can "stop the clock" to ask for more information and clarification. Buts its 90 days from submital to approval or rejection if your paperwork is in order.
Novel devices have a different path.
Once cleared the FDA can and will come by at anytime and do an audit of your processes and if they aren't up to snuff they can shutdown sales.
They definitely broadcast almost-definite timelines. You see regularly SpaceX prepping launch sites for FAA approval that comes less than a day before launch.
