By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health 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
    What Are the Benefits of CBD?
    November 27, 2021
    How to Measure Adult Diapers- The Ultimate Guide to Picking the Right Size
    March 8, 2022
    medicine cabinet
    The Effect Of Finished Dosage Form Manufacturing In New Drugs
    July 5, 2022
    Latest News
    Clean Your Mattress Properly to Avoid Common Health Issues
    March 29, 2023
    5 Benefits Of HIPAA-Compliant Answering Services
    March 28, 2023
    3 Ways To Deal With Health Issues In Cities With High Pollution
    March 22, 2023
    What Tools Should Your Caregiver Have?
    March 22, 2023
  • 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
    I’m OK With Raffles for Fertility Treatment
    October 22, 2012
    Data via ACPM 2010
    5 Keys Ways to Improve Medication Adherence
    May 1, 2015
    The Crown Jewel of ObamaCare Failures
    December 6, 2012
    Latest News
    What Are Bioidentical Hormones Made With?
    March 23, 2023
    Cover Medical Costs of Child Dog Bites with Legal Specialists
    March 23, 2023
    3 Ways to Improve the U.S. Healthcare System By 2030
    March 14, 2023
    6 Steps To Ensure Speed And Efficiency Of Clinical Studies
    March 14, 2023
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA Issues Final Guidance on Mobile Medical Apps
Share
Sign In
Notification Show More
Latest News
improve self-esteem to fight depression
7 Ways to Enhance Your Self-Esteem to Fight Depression
Mental Health
healthy travel tips when visiting Australia
7 Essential Tips to Stay Safe and Healthy Visiting Australia
News
health risks of dirty mattress
Clean Your Mattress Properly to Avoid Common Health Issues
Health
eligble for NDIS?
Are You Eligible For NDIS? How To Apply
News
upgrade to your nursing career
4 Pertinent Ways to Upgrade Your Nursing Career
Nursing
Aa
Health Works CollectiveHealth Works Collective
Aa
Search
Have an existing account? Sign In
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
Last updated: 2013/09/29 at 8:00 AM
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

everest healthcare

The Everest Foundation’s Mission to Support Inclusive Healthcare

Colleges Prove the Huge Benefits of AI in Healthcare Education
Using EHR systems in healthcare for Cost-Effective Services
Benefits of Emerging Technology in Healthcare in 2023
Why Is a Referenced Based Pricing Tool Necessary?

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

Sign Up For Daily Newsletter

Be keep up! Get the latest breaking news delivered straight to your inbox.
By signing up, you agree to our Terms of Use and acknowledge the data practices in our Privacy Policy. You may unsubscribe at any time.
Tim Gee September 29, 2013
Share this Article
Facebook Twitter Copy Link Print
Share
Previous Article Outrages of the Week in Food and Medicine
Next Article medical imaging and meaningful use NYMIIS: Medical Imaging and Meaningful Use – It Is No Longer an Option

Stay Connected

1.5k Followers Like
4.5k Followers Follow
2.8k Followers Pin
136k Subscribers Subscribe

Latest News

improve self-esteem to fight depression
7 Ways to Enhance Your Self-Esteem to Fight Depression
Mental Health March 31, 2023
healthy travel tips when visiting Australia
7 Essential Tips to Stay Safe and Healthy Visiting Australia
News March 29, 2023
health risks of dirty mattress
Clean Your Mattress Properly to Avoid Common Health Issues
Health March 29, 2023
eligble for NDIS?
Are You Eligible For NDIS? How To Apply
News March 29, 2023

You Might also Like

Bioidentical Hormones
Medical Education

What Are Bioidentical Hormones Made With?

March 23, 2023
child dog bite lawyer
News

Cover Medical Costs of Child Dog Bites with Legal Specialists

March 23, 2023
US healthcare system
Global Healthcare

3 Ways to Improve the U.S. Healthcare System By 2030

March 14, 2023
Clinical Studies
Global Healthcare

6 Steps To Ensure Speed And Efficiency Of Clinical Studies

March 14, 2023
//

We influence million of users and is the most authentic source of information on healthcare business and technology news.

Quick Links

  • About
  • Contact
  • Privacy
Subscribe

Subscribe to our newsletter to get our newest articles instantly!

Follow US

© 2008-2023 HealthWorks Collective. All Rights Reserved.

Removed from reading list

Undo
Welcome Back!

Sign in to your account

Lost your password?