Apple joins FDA pilot program allowing it to skip some rules for health products

Posted:
in Apple Watch
Apple has been picked as one of nine companies for a pilot program by the U.S. Food and Drug Administration, which which will let the firms avoid regulations that can slow the development of health-related products.




Under the scheme, companies will be able to get pre-clearance so long as they subject their software and facilities to scrutiny, Bloomberg reported. With this in hand, the formal approval process may become shortened or non-existent.

Over a hundred companies expressed interest in the pilot, the FDA said. Other successful applicants included Fitbit, Samsung, Roche, Johnson & Johnson, and Alphabet's Verily Life Sciences.

In the case of Apple, the FDA program could be applied to things like the Apple Heart Study, but also future versions of the Apple Watch. Apple has allegedly been experimenting with non-invasive glucose detection, something that would require FDA vetting for a shipping product.

Going through the FDA has previously posed risks for the company, not just because of its time-consuming nature but the likelhood of exposing products to competitors long before they launch. While secrets are still likely to slip out, rapid approval could make it possible for Apple to ship medical-related advances before competitors can catch up.

The Apple Watch Series 3 shipped on Sept. 22 with upgrades like LTE, but no radically different health technology.

Comments

  • Reply 1 of 14
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
  • Reply 2 of 14
    dysamoria said:
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
    Its a PILOT program, that's why. Besides, getting FDA approval is a process that moves at glacier speeds, even after a product has been approved in the Euro zone, Canada and Japan (not exactly dubious third world countries)/ More people die awaiting FDA approval than are helped in the 5 - 10 years after release. Also, the glacially slow FDA process is a huge contributor to product (aka drugs) retail prices. Personally I think all drugs that have completed stage 1 testing should be immediately released to the public. FDA approved drugs to be packaged in GREEN containers, while non-approved drugs are packaged in RED containers with clear statements, in large bold typeface, that the drug has not been approved by the FDA and may be hazardous to the users health. Let the sufferer decide how much risk they are willing to take.
    cyberzombiebeowulfschmidt
  • Reply 3 of 14
    512ke512ke Posts: 776member
    I predict that, unfortunately, the FDA is going the way of the EPA and gradually losing its regularly enforcement power.
  • Reply 4 of 14
    I think this is related to the administration in power. Trump is very much pro corporation. . 
  • Reply 5 of 14
    JanNLJanNL Posts: 250member
    tshapi said:
    I think this is related to the administration in power. Trump is very much pro corporation. . 
    Or pro patient, or pro a more swift government.
    It all depends on how you want to look at it...
  • Reply 6 of 14
    calicali Posts: 3,495member
    Considering the FDA can’t keep up with Apple, this is great news!

    Also we can trust Apple more than the FDA at this point.
    edited September 2017 watto_cobra
  • Reply 7 of 14
    dysamoria said:
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
    This is nothing more than the FDA equivalent to the DOT's TSA precheck.  Rather than have to replicate red tape every time you submit something, you cut out the "same old stuff" and do it once.  
  • Reply 8 of 14
    dysamoria said:
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
    Its a PILOT program, that's why. Besides, getting FDA approval is a process that moves at glacier speeds, even after a product has been approved in the Euro zone, Canada and Japan (not exactly dubious third world countries)/ More people die awaiting FDA approval than are helped in the 5 - 10 years after release. Also, the glacially slow FDA process is a huge contributor to product (aka drugs) retail prices. Personally I think all drugs that have completed stage 1 testing should be immediately released to the public. FDA approved drugs to be packaged in GREEN containers, while non-approved drugs are packaged in RED containers with clear statements, in large bold typeface, that the drug has not been approved by the FDA and may be hazardous to the users health. Let the sufferer decide how much risk they are willing to take.
    What?  After Stage 1?  No thanks, maybe after Stage 3.  Stage 1 (phase 1) is just to prove it won't kill you, nothing to do with how well it works.  :)
    farmboy
  • Reply 9 of 14
    dysamoria said:
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
    It’s cute you think that the FDA actually exists to protect the people of the United States. That hasn’t been the case for decades. Why the fuck do you think there’s corn and soy in everything?
    tshapi said:
    I think this is related to the administration in power. Trump is very much pro corporation. . 
    Obama and Clinton allowed it, too. Don’t get political.
    edited September 2017 airnerd
  • Reply 10 of 14
    dysamoria said:
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
    Its a PILOT program, that's why. Besides, getting FDA approval is a process that moves at glacier speeds, even after a product has been approved in the Euro zone, Canada and Japan (not exactly dubious third world countries)/ More people die awaiting FDA approval than are helped in the 5 - 10 years after release. Also, the glacially slow FDA process is a huge contributor to product (aka drugs) retail prices. Personally I think all drugs that have completed stage 1 testing should be immediately released to the public. FDA approved drugs to be packaged in GREEN containers, while non-approved drugs are packaged in RED containers with clear statements, in large bold typeface, that the drug has not been approved by the FDA and may be hazardous to the users health. Let the sufferer decide how much risk they are willing to take.
    Sorry, disagree. We have FDA-regulated devices and have always received our clearance (approval) in a timely manner, consistent with other medical device regulations in other countries. The process is thorough, as it should be. Your libertarian-like "release it and sort out the bodies in the courtroom years later approach is mindless. 
  • Reply 11 of 14

    dysamoria said:
    Wait. What? Why? Regulation exists for very real and important reasons. Why would they just let certain companies slip by with less or zero regulatory process??
    It’s cute you think that the FDA actually exists to protect the people of the United States. That hasn’t been the case for decades. Why the fuck do you think there’s corn and soy in everything?
    tshapi said:
    I think this is related to the administration in power. Trump is very much pro corporation. . 
    Obama and Clinton allowed it, too. Don’t get political.
    FDA is better than equivalent agencies around the world. I speak from experience.

    There's corn and soy in lots of things because those crops are usually economically grown (profitable) in large volumes, temperature-hardy, energy-dense, storable, transportable, and blend well (palatable) with other proteins in meals of most cuisines, so they make for safe and reliable food sources. You can easily avoid or minimize your exposure to these foods if you don't like them, or are one of the rare people that can't tolerate one of them. If you're talking about GMO or HFCS, those are entirely different discussions, in which hysteria seems to be predominant. 
  • Reply 12 of 14
    farmboy said:
    FDA is better than equivalent agencies around the world. I speak from experience.
    Hmm… You’re probably right about that.
    There's corn and soy in lots of things because those crops are usually economically grown (profitable) in large volumes
    Read: subsidies
    If you're talking about GMO or HFCS, those are entirely different discussions, in which hysteria seems to be predominant. 
    I’m most concerned about xenoestrogens, myself. Our water supply is in serious need of a rejiggering. Did you know that there are plastic fibers in 80% of US water?
  • Reply 13 of 14
    JanNL said:
    tshapi said:
    I think this is related to the administration in power. Trump is very much pro corporation. . 
    Or pro patient, or pro a more swift government.
    It all depends on how you want to look at it...
    You mean like putting 100% oil, gas, chemical people at the EPA  in total disregard to the EPA charter (and lying about the charter too)
    .. That sounds like taking a dump in the mouth of people and calling it lunch type government to me.
       But, hey, they're not patient yet, so why should they be protected...
    Or promoting and protecting monopolies and calling it good for people, like that "humanitarian" at the FCC Pai, or..
    Or Orange turd 's constant whining about not destroying the ACA, something that the government auditors says would cut off 30M from all healthcare... What a "good guy".

    If anything come from this "government", it will be entirely accidental, a collateral effect of blow-torching everything else; like WWII was good for the US economy in the 1950s and 1960s except the other allies are part of the US itself in this case.

    All of this being said, fast tracking companies with a strong internal auditing instead of always starting from scratch for every device is not a bad idea for certain types of equipment (which seem to be the case here). If they don't cut corners or give preferential access to big businesses over smaller ones (like at the FCC it would be just the usual level of corruption in government (see FCC)), it would be the right thing to do.



  • Reply 14 of 14
    rightbydesignrightbydesign Posts: 1unconfirmed, member
    Apple is now the first company to get FDA approval for their watch with EKG monitoring. This is HUGE! People's lives will be saved by this watch - libs would rather they die to ensure their hardcore position on government regulation.
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