Apple Joins FDA Pilot Program for Faster Approval of Digital Health Tools

Discussion in ' News Discussion' started by MacRumors, Sep 26, 2017.

  1. MacRumors macrumors bot


    Apr 12, 2001

    The Food and Drug Administration today announced that it has selected nine companies to join its voluntary Pre-Cert pilot program, which is designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products.

    Companies accepted to the program include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.

    With its program, the FDA is aiming to create a more tailored approach toward digital health technology by looking at the software developer rather than the product to establish a firm-based pre-certification program for these digital health tools. The companies accepted to the program will be reviewed for software design, validation, and maintenance and to determine if they meet the FDA's quality standards for pre-certification.

    Companies who have been pre-certified may be able to submit less information to the FDA before marketing a new digital health tool, speeding up the approval of new services and technologies. The FDA is also considering allowing pre-certified companies to avoid submitting products for premarket review in some situations.

    As part of the program, Apple will provide the FDA with access to the measures it use to develop, test, and maintain software products. Apple has agreed to allow visits from FDA staff and offer information about its quality management system.
    For Apple, this program could be a major boon as it has several digital health-related tools like Health, CareKit, and ResearchKit, and FDA approval is likely one of the major roadblocks to releasing new health-related products that are rumored to be in the works, such as some kind of device for monitoring blood glucose.

    Apple CEO Tim Cook has said that Apple does not want to put the Apple Watch through the FDA approval process, but should the program go well, Apple may also have fewer regulations to contend with when it comes to the future of the Apple Watch, which could allow for new, more advanced health-monitoring capabilities.

    Article Link: Apple Joins FDA Pilot Program for Faster Approval of Digital Health Tools
  2. tzm41 macrumors regular


    Jul 11, 2014
  3. filmantopia macrumors 6502a


    Feb 5, 2010
    Great news.
  4. ksnell macrumors 6502a


    Aug 26, 2012
    Really great news.
  5. iabacus macrumors member


    Sep 26, 2011
    The FDA is a joke, fully bought and sold by big Pharma. How many deadly medications have gone to market to later be pulled. Software and non-invasive monitoring should not be under their umbrella.
  6. filmantopia macrumors 6502a


    Feb 5, 2010
    Oh and I'm sure next you're going to say the insurance companies are trying to buy politicians, and big oil is covering up climate change science, and the military industrial complex has an endless war agenda.

    And you would be right.
  7. iLoveDeveloping macrumors 6502

    Sep 24, 2009
    Excellent news!!! This Apple Watch is about to become a revolutionary product after all! This will change the whole face of healthcare, potentially saving millions of people that otherwise would die prematurely. Can't wait to see what's coming.
  8. 69Mustang, Sep 26, 2017
    Last edited: Sep 26, 2017

    69Mustang macrumors 603


    Jan 7, 2014
    In between a rock and a hard place
    Oooookay. There's reaction, overreaction, and whatever this is. I don't know what this is. I do know it's not chili. Real chili doesn't have beans in it. This has beans.
  9. BeefCake 15 macrumors 65816

    BeefCake 15

    May 15, 2015
    near Boston, MA
    Wonderful News!
  10. shk718 macrumors 65816

    Jun 26, 2007
    this should speed up apple watch development quite a bit!!!!
  11. OldSchoolMacGuy Suspended


    Jul 10, 2008
    It's a hard deal. It would be huge to have glucose monitoring and other information built-into the Apple Watch. But the money required for FDA approval and the strict compliance would likely drive the cost of the watch way up. It'd likely have to be a special model for those that really need it as it's likely to increase the price fo the device by double, if not more.
  12. BornAgainMac macrumors 603


    Feb 4, 2004
    Florida Resident
    And maybe speed up Mac Mini development.
  13. RickInHouston macrumors 65816

    May 14, 2014
    Billions of dollars, part of which where sitting in a bank are helping lobby for something!
  14. JaySoul macrumors 68030


    Jan 30, 2008
    This is THE most exciting part of wearable fitness.
  15. FelixDerKater Contributor


    Apr 12, 2002
    Nirgendwo in Amerika
    Apple-friendly margins are readily available in that sector.
  16. shk718 macrumors 65816

    Jun 26, 2007
    i don't care about mac mini - i care about apple watch.
  17. seatton macrumors 6502a


    Nov 7, 2013
    Seattle, WA
    I only want a sleep tracking feature. Then, I am interested in an Apple Watch Edition (I have a SS series 0 and series 3).
  18. DblHelix macrumors 6502

    Mar 19, 2009
    I want proper sleep tracking and a device that either lasts a week on charge or preferably some type of automatic movement that charges while I move
  19. FelixDerKater Contributor


    Apr 12, 2002
    Nirgendwo in Amerika
    Do you think they will come up with some accessory for sleep tracking since the watch itself needs nightly charging?
  20. kdarling macrumors P6


    Jun 9, 2007
    First university coding class = 47 years ago
    I don't see how. Apple has always been able to apply for Watch certification for a couple of years, but apparently has not done so.

    This pre-certification might shave a month or several off approvals, but it's not years. However, it will help later with software updates.
  21. xalea macrumors regular


    Jan 12, 2017
    And yet it won't.
  22. thisisnotmyname macrumors 68000


    Oct 22, 2014
    known but velocity indeterminate
    This is wonderful news. The FDA bureaucracy has been a big barrier to consumer tech augmenting and integrating with medical. There is a difficult balance to strike here to make sure that our collective health in maintained while reducing the obstacles to innovation on the consumer facing side. I hope this works out well.
  23. NomadicTy macrumors regular

    Feb 11, 2007
    We're from the government. And we're here to help! /sarc
  24. trusso Suspended

    Oct 4, 2003
    How you say in English? Um... "Famous last words." :rolleyes:
  25. willzyx macrumors member

    Dec 21, 2016
    And how many people would die if it weren't for FDA and their constant tests? Without FDA, even your neighbor would make "medications" that cure everything. And to answer your question, not many medications were pulled because they failed. 35 to be exact. 35 medications were pulled out of thousands that were approved since 1970s.
    So yes, be grateful that FDA is around.

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