5 ms·

> This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and

by abtinf 2y ago

> This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed device”? How much more onerous is the normal pathway?

tootie 2y ago
Sony already has OTC hearing aids on the market
- CharlesW 2y ago
  Neat: https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-hearing-aid https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-... So what does "first OTC Hearing Aid Software" mean, given that both are hardware/software systems?
  - Spooky23 2y ago
    It does some tuning based on a hearing test.
  - tootie 2y ago
    It seems like it's software to conduct a hearing evaluation to tune the airpods. There's actually loads of OTC hearing aids on the market already although most seem fairly pricey.
squidgedcricket 2y ago
> Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed device”? Nope, they'd use the 510k process, which is less onerous than de novo. De novo is a quicker alternative to the traditional path for brand new classes of devices. The 510k process is used to develop a new device within an existing class.
ijustlovemath 2y ago
Med device startup cofounder here. In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways): 1. Pre Market Approval: you're addressing a completely unproven technology in a novel and or dangerous space. Usually Class II and above. 2. De Novo: you're adding a new technology to a somewhat well known space. Usually Class II+ 3. 510(k): There's already something in the market that addresses a similar problem and works using similar technology to your device. FDA understands these things well and have a very clear approval guideline, which usually just takes time to rubber stamp if the submission is of sufficiently high quality. This is all ignoring Breakthrough Medical Devices, which have a ton of red tape cut (max 30 days to hear back about any submission, and if they run out of time, it's an approval). These kinds of devices are pretty rare, though.
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- dannyw 2y ago
  As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
  - cruffle_duffle 2y ago
    Why? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”. There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections. It’s just an SLA and holds people accountable.
  - ijustlovemath 2y ago

by abtinf 2y ago

tootie 2y ago

Sony already has OTC hearing aids on the market

CharlesW 2y ago
Neat: https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-hearing-aid https://electronics.sony.com/more/otc-hearing-aid/c/all-otc-... So what does "first OTC Hearing Aid Software" mean, given that both are hardware/software systems?
- Spooky23 2y ago
  It does some tuning based on a hearing test.
- tootie 2y ago
  It seems like it's software to conduct a hearing evaluation to tune the airpods. There's actually loads of OTC hearing aids on the market already although most seem fairly pricey.

squidgedcricket 2y ago

> Does that mean that if Android/Bose/Sony/etc were to develop a comparable solution, they would not be able to use the “De Novo premarket review pathway” because AirPods Pro is now a “prior legally marketed device”? Nope, they'd use the 510k process, which is less onerous than de novo. De novo is a quicker alternative to the traditional path for brand new classes of devices. The 510k process is used to develop a new device within an existing class.

ijustlovemath 2y ago

Med device startup cofounder here. In terms of difficulty in your path to market, from hardest to easiest (and ignoring some less common pathways): 1. Pre Market Approval: you're addressing a completely unproven technology in a novel and or dangerous space. Usually Class II and above. 2. De Novo: you're adding a new technology to a somewhat well known space. Usually Class II+ 3. 510(k): There's already something in the market that addresses a similar problem and works using similar technology to your device. FDA understands these things well and have a very clear approval guideline, which usually just takes time to rubber stamp if the submission is of sufficiently high quality. This is all ignoring Breakthrough Medical Devices, which have a ton of red tape cut (max 30 days to hear back about any submission, and if they run out of time, it's an approval). These kinds of devices are pretty rare, though.

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dannyw 2y ago
As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
- cruffle_duffle 2y ago
  Why? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”. There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections. It’s just an SLA and holds people accountable.
- ijustlovemath 2y ago