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

healthappupdateThe 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.

Top Rated Comments

filmantopia Avatar
61 months ago
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.
Score: 7 Votes (Like | Disagree)
69Mustang Avatar
61 months ago
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.
Score: 6 Votes (Like | Disagree)
iabacus Avatar
61 months ago
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.
Score: 3 Votes (Like | Disagree)
JaySoul Avatar
61 months ago
This is THE most exciting part of wearable fitness.
Score: 2 Votes (Like | Disagree)
Z400Racer37 Avatar
61 months ago
You mean.... Regulation stifles innovation? No.... Shocker...
Score: 1 Votes (Like | Disagree)
ravenstar Avatar
61 months ago
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.
Or perhaps drug safety analysis is a very complex and difficult task that even the best authorities sometimes get wrong. Yes, there have been some high profile withdrawals, but that hardly means the FDA is a joke. I recall the general public complaining that the FDA was taking too long to approve drugs. Seems like it's not just the FDA that's to blame for these errors.
Score: 1 Votes (Like | Disagree)

Popular Stories

iOS 16 mock for article

Gurman: iOS 16 to Include New Ways of System Interaction and 'Fresh Apple Apps'

Sunday May 15, 2022 6:14 am PDT by
iOS 16 will include new ways of interacting with the system and some "fresh Apple apps," Bloomberg's Mark Gurman has said, offering some more detail on what Apple has in store for the upcoming release of iOS and iPadOS set to be announced in a few weeks at WWDC. In the latest edition of his Power On newsletter, Gurman wrote that while iOS 16 is not likely to introduce a major face-lift to...
maxresdefault

Unbox Therapy Shares Hands-On Look at iPhone 14 Pro Max Replica

Monday May 16, 2022 4:40 am PDT by
YouTuber Unbox Therapy has shared a hands-on look at the iPhone 14 Pro Max using what he claims is a one-to-one replica created by third-party case makers with access to detailed schematics and dimensions for Apple's new upcoming flagship smartphone. As with the iPhone 13 Pro lineup, in 2022, we are expecting a 6.1-inch iPhone 14 Pro and a 6.7-inch iPhone 14 Pro Max, but this time the Pro...
RIP iPod Feature

RIP iPod: A Look Back at Apple's Iconic Music Player Over the Years

Friday May 13, 2022 2:25 pm PDT by
Apple earlier this week announced the discontinuation of the iPod touch, and because it was the last iPod still available for purchase, its sunsetting effectively marks the end of the entire iPod lineup. To send the iPod on its way, we thought it would be fun to take a look back at some of the most notable iPod releases over the last 21 years. Original iPod (2001) Introduced in October...
macOS Monterey 2

Apple Releases macOS Monterey 12.4 With Support for Studio Display Webcam Update

Monday May 16, 2022 10:10 am PDT by
Apple today released macOS Monterey 12.4, the fourth major update to the macOS Monterey operating system that launched in October 2021. macOS Monterey 12.4 comes over two months after the launch of macOS Monterey 12.3, an update that added Universal Control. The ‌‌‌‌‌macOS Monterey‌‌ 12.4 update can be downloaded on all eligible Macs using the Software Update section of System...
iOS 15

Apple Releases iOS 15.5 and iPadOS 15.5 With Wallet and Podcast Updates

Monday May 16, 2022 10:00 am PDT by
Apple today released iOS 15.5 and iPadOS 15.5, the fifth major updates to the iOS and iPadOS 15 operating systems that were initially released in September 2021. iOS and iPadOS 15.5 come a little over two months after the launch of iOS 15.4 and iPadOS 15.4. The iOS 15.5 and iPadOS 15.5 updates can be downloaded for free and the software is available on all eligible devices over-the-air in...
airpodsprodesign

Kuo: AirPods, MagSafe Battery Pack, and Other Apple Accessories Also to Switch to USB-C in Future

Sunday May 15, 2022 5:59 am PDT by
Earlier this week, well-known Apple analyst Ming-Chi Kuo claimed that Apple plans to release at least one iPhone 15 model with a USB-C port in 2023. Now, in a follow-up tweet, he has claimed that accessories like AirPods, the MagSafe Battery Pack, and the Magic Keyboard/Mouse/Trackpad trio would also switch to USB-C in the "foreseeable future." Both the iPhone and all of the aforementioned...
apple tv 4k design green

Apple Releases tvOS 15.5 for Apple TV HD and Apple TV 4K

Monday May 16, 2022 9:57 am PDT by
Apple today released tvOS 15.5, the fifth major update to the tvOS operating system that first launched in September 2021. tvOS 15.5 comes more than two months after the release of tvOS 15.4, an update that brought support for captive WiFi networks. tvOS 15.5 can be downloaded over the air on the Apple TV through the Settings app by going to System > Software Update. ‌‌‌‌‌‌Apple...