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

MacRumors

macrumors bot
Original poster
Apr 12, 2001
46,437
8,794



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.
"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," said Dr. Gottlieb. "We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
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
 
  • Like
Reactions: DeepIn2U

iabacus

macrumors member
Sep 26, 2011
73
128
Hawaii
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.
 

filmantopia

macrumors 6502a
Feb 5, 2010
685
1,664
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.
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.
 

iLoveDeveloping

macrumors 6502
Sep 24, 2009
323
809
Ireland
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.
 
  • Like
Reactions: deany

69Mustang

macrumors 604
Jan 7, 2014
6,974
12,586
In between a rock and a hard place
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.
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.
 
Last edited:

OldSchoolMacGuy

Suspended
Jul 10, 2008
4,197
8,906
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.
 

seatton

macrumors 6502a
Nov 7, 2013
714
1,070
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).
 

DblHelix

macrumors 6502
Mar 19, 2009
377
236
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).
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
 

thisisnotmyname

macrumors 68020
Oct 22, 2014
2,252
4,637
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.
 

trusso

macrumors 6502
Oct 4, 2003
367
902
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.

How you say in English? Um... "Famous last words." :rolleyes:
 

willzyx

macrumors regular
Dec 21, 2016
108
168
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.
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.