United States: The FDA Releases Long-Awaited Final Guidance On Mobile Medical Applications

On September 23, 2013, the U.S. Food and Drug Administration (the "FDA" or the "Agency") issued long-awaited final guidance for developers of mobile medical or health applications (or "mobile medical apps") used on smartphones and other mobile devices. The final guidance reflects a tailored approach by the Agency to analyzing mobile medical apps, and represents an important step in narrowing the field of interpretation of the current laws.

The Agency's guidance indicates its intention to exercise enforcement discretion for most mobile medical apps on the basis that they pose minimal risk to consumers. Instead, the FDA will largely focus its enforcement attention on the functionality of the mobile applications and give greater consideration to those applications that the Agency believes present "a greater risk to patients if they do not work as intended."

The final guidance comes over two years after the Agency published draft guidelines, and encompasses the comments of industry respondents which overwhelmingly supported a customized, risk-based approach. The FDA's final statements reflects the Agency's interest in balancing regulatory oversight with support of innovation in medicine and technology.

The final guidance focuses on mobile applications and not their platforms. Under the guidance, the FDA will not regulate the sale or general/conventional consumer use of smartphones or tablets.

What are mobile medical apps?

For purposes of the guidance, a mobile application is defined as a software application that can run on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.

A "mobile medical app" that is subject to regulatory oversight by the FDA is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "FD&C Act") and either is intended:

  • to be used as an accessory to a regulated medical device (e.g., mobile apps that display medical device data to perform active patient monitoring, mobile apps that provide the ability to control the inflation or deflation of a blood pressure cuff through a mobile platform, or mobile apps that display, store or transfer medical data in its original format); or
  • to transform a mobile platform into a regulated medical device (e.g., attaching a blood glucose strip reader to a mobile platform to function as a glucose meter, or performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations).

The FDA will look at the intended use of a mobile app to determine whether it meets the definition of a "device." Intended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is considered a "device." To provide additional clarification, Appendix C of the guidance as well as the FDA's Products and Medical Procedures website contain a non-exhaustive list of examples of mobile apps that are the focus of the FDA's regulatory oversight.

Many mobile apps involving health will not considered mobile medical apps because they do not meet the definition of a "device" under the FD&C Act. The FDA has indicated that the following mobile apps would not be considered a "device":

  1. Mobile apps that are intended to be used as reference materials or for user or patient education and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional's assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment.

    This includes mobile apps that are:
    • intended to provide access to electronic "copies" (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities;
       
    • intended for health care providers to use as educational tools for medical training or to reinforce training previously received; and
       
    • intended for general patient education and facilitate patient access to commonly used reference information. These apps can be patient-specific (i.e., filters information to patient-specific characteristics), but are intended for increased patient awareness, education, and empowerment, and ultimately support patient-centered health care.
       
  2. Mobile apps that automate general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
     
  3. Mobile apps that are generic aids or general purpose products, such as mobile apps that allow patients or healthcare providers to interact through email, web-based platforms, video or other communication mechanisms (but are not specifically intended for medical purposes).

If a mobile app does not meet the definition of a "device" under the FD&C Act, the app will not be considered a mobile medical app for purposes of the guidance.

Will all mobile medical apps be regulated?

No. The fact that a mobile app meets the definition of a medical device does not necessarily indicate that the FDA will regulate it under the current laws. The Agency noted that it intends to exercise enforcement discretion over some mobile apps that meet the definition of a medical device if they pose a lower safety risk to the public. This means that the FDA will not consider these mobile apps to be "mobile medical apps" for purposes of the guidance and will not enforce the requirements under the FD&C Act. Appendix B of the guidance and FDA's Products and Medical Procedures website contains examples of such mobile apps. Such mobile apps include (but are not limited to):

  1. Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder, depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a "Skill of the Day" behavioral technique or audio messages that the user can access when experiencing increased anxiety;
  2. Mobile apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women;
  3. Mobile apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location;
  4. Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home;
  5. Mobile apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
  6. Mobile apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks;
  7. Mobile apps that prompt the user to manually enter symptomatic, behavioral or environmental information, the specifics of which are pre-defined by a health care provider, and store the information for later review;
  8. Mobile apps that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-known and established authorities;
  9. Mobile apps that record the clinical conversation a clinician has with a patient and sends it (or a link) to the patient to access after the visit;
  10. Mobile apps that are intended to allow a user to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology;
  11. Mobile apps that enable a patient or caregiver to create and send an alert or general emergency notification to first responders; and
  12. Mobile apps that keep track of medications and provide user-configured reminders for improved medication adherence.

In an effort to demonstrate support for innovation in an industry that has shown immense growth in the past few years, the FDA noted that a majority of mobile apps on the market at this time either will not fit the definition of a device or will pose a lower safety risk to the public, and thus will not be considered mobile medical apps or be regulated by the FDA.

What Must Companies that Manufacture Mobile Apps Do?

The FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System Regulation set forth under Title 21 of the Code of Federal Regulations Part 820 (which includes good manufacturing practices) in the design and development of their mobile medical apps. The FDA also recommends that such companies initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.

For mobile medical apps, manufacturers must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification. A mobile medical app, like other devices, may be classified as Class I (General Controls), Class II (Special Controls in addition to General Controls), or Class III (Premarket Approval).

What Does the Guidance Not Cover?

The guidance does not address the approach for software that performs patient-specific analysis to aid or support clinical decision-making. Also, the FDA's policies regarding accessories to medical devices are not unique to mobile medical apps and go beyond the scope of the guidance. Specifically the guidance does not address the FDA's general approach for accessories to medical devices.

Is the Guidance Binding?

The FDA's guidance on mobile medical apps does not establish legally enforceable responsibilities. Instead, the guidance describe the FDA's current thinking on a topic and should be viewed as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in the guidance means that something is suggested or recommended, but not required. A company could use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

What to Do Next?

The FDA recommends that mobile medical app developers should contact the FDA as early as possible if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.

Companies can also find more information at the Mobile Medical Applications Web Page and at the FDA's website for consumers entitled Consumer Update: Keeping Up with Progress in Mobile Medical Apps.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Events from this Firm
15 Nov 2018, Other, San Diego, United States

The University of San Diego's Center for Cyber Security Engineering and Technology will host this upcoming Symposium in Cyber Law, Risk and Policy to be held on the beautiful USD campus.

15 Nov 2018, Speaking Engagement, San Francisco, United States

EMPOWERED WOMEN MAKING A DIFFERENCE: Give back to your community and change a life with Sheppard Mullin’s Women Lawyers Group

16 Nov 2018, Other, Los Angeles, United States

Sheppard Mullin partner Jonathan Aronie will speak on “Careers in White Collar Practice and Corporate Compliance” panel at Duke Law.

Similar Articles
Relevancy Powered by MondaqAI
Klein Moynihan Turco LLP
Wilson Elser Moskowitz Edelman & Dicker LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Klein Moynihan Turco LLP
Wilson Elser Moskowitz Edelman & Dicker LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions