United States: FDA Final Guidance On Mobile Medical Applications

Last Updated: November 27 2013
Article by Peter A. Blenkinsop, Reed Abrahamson and Krissa Webb

On September 23, 2013, the FDA issued a guidance ("Final Guidance") explaining how medical device regulations will be applied to medical mobile applications (MMAs).1 The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.

The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement discretion because these applications pose a low risk to the public; and (3) mobile apps that meet the definition of a medical device and which the FDA will regulate due to the significant potential risk to patient safety.

Parties Subject to Regulation

The Final Guidance applies to mobile application manufacturers—any person or entity that manufactures MMAs in accordance with the definitions of "manufacturer" found in 21 CFR Parts 803, 806, 807, and 8202—including those who initiate specifications, design, label, or create the application. The Guidance indicates that when a developer (i.e., an entity that provides engineering, design, and development services) creates a mobile medical app in accordance with a third-party's specifications (the "author"), it is the author who is considered the "manufacturer." The Guidance states that entities exclusively involved in the distribution of mobile medical applications (e.g., Apple's "App Store") will not be considered "manufacturers." The Guidance similarly states that the FDA does not intend to regulate manufacturers or distributors of mobile platforms (e.g., smartphones and tablets) marketed for general use.

Mobile Applications Subject to Regulation

The FDA has jurisdiction to regulate "medical devices," defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory ... which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease."3 A mobile app intended for medical use falls under the definition of a "medical device," a determination made by evaluating labeling claims, advertising materials, and statements by manufacturers and their representatives.

The Final Guidance indicates that FDA will regulate MMAs that either (1) are intended to be used as an accessory to a regulated medical device or (2) transform a mobile platform into a regulated medical device. Specifically, the FDA will regulate three categories of mobile apps:

  1. Mobile apps that act as an extension of a medical device by connecting to the device in order to control the device or display, store, analyze, or transmit patient-specific data. For example: mobile applications that control delivery of insulin by an insulin pump or that control inflation of a blood pressure cuff, as well as apps for remote display of patient monitors or remote display of radiological images from a Picture Archiving and Communications (PACS) server. This category also includes Medical Device Data System (MDDS) apps that display, store, or transmit medical device data in their original form without controlling or altering the functions of any connected device. MMAs that fall under this category are generally subject to the regulations governing the medical device to which they operate as an extension.
  2. Mobile apps that transform a mobile platform into a medical device by using attachments, display screens, or sensors or other medical device functionalities. For example: an application that allows a mobile platform to operate as a glucose meter through an attachment to a glucose strip reader; an app that turns a smartphone into an electronic stethoscope through an attachment to an external sensor; or an app that measures EKG signals through the use of external electrodes. MMAs that fall under this category must comply with the device classification associated with the transformed platform.
  3. Mobile apps that become a regulated medical device by performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations. For example: mobile applications that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy. The Final Guidance indicates that these types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved. FDA gives as examples mobile apps that perform "sophisticated analysis" or interpret data from another device. In this case, manufacturers are encouraged to contact the FDA to determine what regulatory requirements may apply.

Mobile app manufacturers should consult the Final Guidance to determine whether their mobile app is subject to regulation. When a mobile app falls within the category of regulated applications, the manufacturer should determine which device classification level applies. The Final Guidance explains how to classify an MMA and directs manufacturers to the appropriate set of regulations. Regardless of classification, however, all MMA manufacturers will be required to comply with the FDA's "General Controls" for medical devices, including regulations that cover establishment registration and device listing; pre-market safety and effectiveness investigations; labeling; pre-market clearance; adverse event reporting; and corrections and removals.

Mobile Applications Not Subject to Regulation

Certain mobile apps that meet the definition of a "medical device" will not be regulated at this time because the FDA has determined that these apps pose fewer risks to patients. This includes the following categories:

  1. Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment. The Final Guidance indicates that this category includes medication reminder apps intended to improve adherence, as well as apps that coach patients with specific conditions and promote strategies for maintaining health.
  2. Mobile apps that provide patients with simple tools to organize and track their health information. These apps may allow patients to input measurements and symptoms, but they do not provide any specific recommendations nor are intended to alter a previously prescribed treatment or therapy.
  3. Mobile apps that provide easy access to information related to patients' health conditions or treatments (beyond providing an electronic "copy" of a medical reference). These apps match patient-specific inputs regarding diagnosis, treatment, allergies, and/or symptoms to clinical reference information.
  4. Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions. This would include, for example, apps that enable an individual to use a smartphone camera to take a photo of his/her condition and transmit the information to a healthcare provider.
  5. Mobile apps that perform simple calculations routinely used in clinical practice. The underlying algorithms must be derived from and available in medical sources and texts. This would include, for example, apps for calculating Body Mass Index (BMI), mean arterial pressure, or APGAR score.
  6. Mobile apps that enable individuals to interact with personal or electronic health record systems. These apps allow patients to download and view information in their PHR or EHR.

Finally, the Final Guidance recognizes that some health-related mobile apps do not meet the definition of a medical device. These apps will not be subject to the FDA's regulations. The Guidance provides a non-exhaustive list of mobile apps that are not considered medical devices. The list includes:

  1. Mobile apps that are intended to provide access to electronic copies of medical textbooks or other reference materials.
  2. Mobile apps that are intended for health care providers to use as educational tools for medical training.
  3. Mobile apps that are intended for general patient education.
  4. Mobile apps that automate general office operations in a health care setting that are not intended for the diagnosis or treatment of disease.
  5. Mobile apps that are generic aids or general purpose products.

Manufacturers of both types of unregulated mobile apps should continue to monitor statutory and regulatory developments which may lead to future oversight. MMA developers should also remain aware of other regulations that affect mobile apps, including privacy rules enforced by the FTC and state governments, and U.S. export requirements concerning applications that use encryption. Distributors of mobile apps may contractually impose requirements as well.

Conclusions

The Final Guidance is good news for the health care community. The FDA's voluntary limitation of enforcement authority shows that the FDA appreciates the need for innovation and the development of applications that improve individual health habits and health care quality.

Importantly, the Final Guidance does not address either clinical decision-making support tools or electronic health records. These issues may be addressed in January 2014, when the FDA, in conjunction with the National Coordinator for Health Information Technology, releases a report describing a risk-based regulatory framework for health information technology.

Footnotes

1 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (2013), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf ("Guidance").

2 "Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term includes any person who:

(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user or consumer;

(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; or

(3) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and are intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient." 21 CFR § 806.2.

3 21 USC § 321(h).

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
Krissa Webb
 
In association with
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
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

    Disclaimer

    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

    Registration

    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

    Cookies

    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

    Links

    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

    Mail-A-Friend

    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

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