By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    medicare part d benefits
    Everything that You Need to Know About Medicare Part D
    August 15, 2022
    Best Ways to Boost Your Immune System this Winter
    Best Ways to Boost Your Immune System this Winter
    November 15, 2022
    back pain issues
    Ways to Treat Constant Back Pain
    August 21, 2023
    Latest News
    How Probate Planning Shapes the Future of Your Estate and Family Care
    July 17, 2025
    Beyond Nutrition: Everyday Foods That Support Whole-Body Health
    June 15, 2025
    The Wide-Ranging Benefits of Magnesium Supplements
    June 11, 2025
    The Best Home Remedies for Migraines
    June 5, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    More On Wellness Programs To Improve Health and Reduce Costs
    January 25, 2012
    Privatizing Social Security and Medicare: Who Can Defuse Political Dynamite?
    June 12, 2011
    Study: Risk of Death in Elderly Patients with Dementia Doubled with Some Antipsychotic Medications
    February 26, 2012
    Latest News
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
    How Health Choices and Legal Actions Intersect After an Injury
    July 17, 2025
    How communities and healthcare providers can address slip and fall injuries with legal awareness
    July 17, 2025
    Let Your Lawyer Handle the Work Before You Pay Medical Costs
    July 6, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Issues Final Guidance on Mobile Medical Apps
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > eHealth > Mobile Health > FDA Issues Final Guidance on Mobile Medical Apps
eHealthMobile HealthPolicy & Law

FDA Issues Final Guidance on Mobile Medical Apps

Tim Gee
Tim Gee
Share
6 Min Read
FDA mobile medical app
SHARE

FDA mobile medical appA bit more than two years after releasing their draft guidance, FDA has released the final guidance (pdf) on mobile medical apps (FDA press release).

FDA mobile medical appA bit more than two years after releasing their draft guidance, FDA has released the final guidance (pdf) on mobile medical apps (FDA press release). FDA also put up a new page on their web site with information on mobile medical apps.

In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:

  • to be used as an accessory to a regulated medical device; or
  • to transform a mobile platform into a regulated medical device.

As always with FDA, the question of whether a mobile app is regulated or not, will be decided on the intended use or claims made by the manufacturer as described in promotional materials, user manuals and similar content and communications.

More Read

The High Healthcare Costs of Emergency Department Visits: Stop Pointing Fingers and Begin Offering Solutions
Federal Legislation Introduced to Allow Telemedicine
“Clinical First” EMR is Physician-Friendly
The Future of Healthcare and Big Pharma is in Big Data Analytics
Why Medical Marketers Shouldn’t Forget About Bing and Yahoo

FDA references two pages of examples of mobile medical apps.  The first list includes Class II medical devices that have received premarket clearance (aka, a 510k). Anyone can submit a 510k for clearance for any kind of device – whether FDA really thinks its a medical device or not. Consequently, this list is not an absolute guide to what FDA considers a mobile medical app that they want to regulate. Unfortunately, the page does not include any links to product information or information on the 510k summary for each product. A search on the “K number” in the FDA’s 510k database, e.g., K020866 for Abbott’s Freestyle Tracker Diabetes Management System, will return a 510k summary for the product, including intended use, classification and product code.

The second list is a reproduction of the final guidance Appendix C, Examples of mobile apps that are the focus of FDA’s regulatory oversight (mobile medical apps). Here, examples of products FDA intends to regulate are described, along with possible product codes. (For more information, FDA’s page on product codes is here.)

This guidance process was not without some controversy. One group, lead by Brad Thompson and the mHealth Regulatory Coalition, was pushing for a quick publication of the final guidance in an effort to end the existing ambiguities around regulating mobile medical apps. Another group, was lobbying for a delay of the final guidance until the FDASIA Workgroup completed their recommendations on the potential (inevitable, really) regulation of health care IT (HIT). Thompson replied, noting that waiting for legislation as suggested by the “delay guidance” group would take months or years, and the market would benefit from a reduction of ambiguity regarding mobile medical apps now.

Interestingly, the FDASIA Workgroup recommendations are mostly in line with FDA’s final guidance on mobile medical apps. It appears that FDA sought to reduce regulatory uncertainty regarding mobile medical apps in the short term, while looking to address some of the more broad issues raised by the FDASIA Workgroup in the medium to long term.

So, does the final guidance change anything? No, not really.

In this final guidance FDA has repeated, once again, that if a product meets the legal definition of a medical device, FDA can regulate it as a medical device – regardless of whether it’s something traditional like a stethoscope or patient monitor, or something that was never envisioned when the FDA was created, like computer software or mobile computing platforms. (The same goes for HIT, but that’s a topic for another blog post.)

For a developer of mobile apps a first step is to determine whether FDA is going to want to regulate it. Any company making products for health care should complete an analysis of whether their product is a medical device or not – and why. This determination should include details on how the intended use and claims of the product might or might not shift the product from not being regulated to being a regulated medical device, and vice a versa. If you’re not already regulated, with a regulatory affairs staff, get an outside regulatory affairs expert to assist.

In the guidance and on their mobile medical apps web page, FDA encourages companies to seek clarification from FDA. Certainly in matters of controversy, the FDA is the final and ultimate word. Be aware that how one goes about asking questions of the FDA can unintentionally commit the company to a certain course of action with FDA. If your company is not already regulated, always get a knowledgeable person to frame things and interact with FDA to maintain maximum flexibility in how, or whether, your product is regulated.

(mobile medical app / shutterstock)

TAGGED:FDA
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
How IT and Marketing Teams Can Collaborate to Protect Patient Trust
Global Healthcare Policy & Law
July 17, 2025
paramedics in surgical gloves and masks
How Health Choices and Legal Actions Intersect After an Injury
Health care
July 16, 2025
a woman giving a key
How Probate Planning Shapes the Future of Your Estate and Family Care
Health
July 16, 2025
a woman with kinesio tapes on her back arm
How communities and healthcare providers can address slip and fall injuries with legal awareness
Health care
July 16, 2025

You Might also Like

Healthcare IT Pain Points
eHealthMedical RecordsSocial Media

What Are Your Health IT Pain Points?

June 18, 2014
healthcare marketing statistics
BusinesseHealthFinanceHospital Administration

23: Number of Useful Internet Marketing Stats in This Healthcare Post

April 24, 2013

3 Trends Shaping the Face of Healthcare Marketing

August 21, 2015
Image
Social Media

6 Ways to Promote Health Care Blogs

March 20, 2012
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?