© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
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Building a Mobile Medical App and Understanding FDA Regulatory Requirements Jason King
Smartphone adoption around the world is With the growing adoption of mobile rapidly growing with an estimated number of applications within the healthcare arena, the users at 1.2 billion in 2012 reaching 4.4 billion question arises: how exactly are apps develusers in 2017.1 In light of this widespread oped? More importantly, at what point does adoption of smartphones, many companies the FDA need to regulate your app, and how have been sent scrambling to take advantage do companies obtain FDA clearance? The of the new technology and build mobile aim of this article is to examine and explain applications that can help their clients, the development and deployment of medical employees, business partners, and managemobile apps from start to finish. ment team. In the world of healthcare, mobile medical How to Develop Medical apps can help consumers manage their own Mobile Applications health and wellness, promote healthy living, The most important thing to remember and gain useful information when and where when developing a mobile application is that they need it. Industry estimates show that you are in fact, creating a new product that 500 million smartphone users will be using a you are bringing to the market. As a medical healthcare application by this year,2 and by product, it will face the standard concerns of 2018, 50% of smartphone users will be using patient safety, user safety, and risk managea mobile medical app.3 ment. Whether the mobile app is a The Healthcare Information and Managestandalone product, works in conjunction ment Systems Society (HIMMS) released a with an existing product, or enhances a study in 2013 that showed the use of mobile service you provide, mobile applications need devices in hospitals and to be well researched, healthcare facilities is on planned out, and properly In the world of healthcare, the rise.4 In 2012, 45% of executed in order to be mobile medical apps can clinicians were using a effective. Always rememhelp consumers manage mobile device to collect ber that these mobile data at a patient’s bedside, their own health and applications are an an increase from 30% in extension of your brand. wellness, promote healthy 2011. Similarly, 34% of First we are going to go living, and gain useful those clinicians were moniover the steps involved in information when and toring patient data from creating a mobile applicawhere they need it. mobile devices, up from tion, and then we will 27% just a year before.4 take a look at which types
About the Author
Biomedical Instrumentation & Technology March/April 2015
Jason King is the president of Accella LLC. E-mail jason.king@ accella.net
99
© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
of apps need FDA clearance and how that process works.
choose to use your app over other mobile apps or other options outside of mobile applications?
The App Development Process There are six main steps in taking a mobile application from concept to creation; you will notice that many of these will mirror steps you would take while launching any product.
Building an app requires thought and serious attention to detail; this part of the development process will lay the foundation and set the tone for overall success of the app.
1. Strategy, Safety Requirements, Risk Management, and Architecture Phase During the initial stage of developing a mobile application, plans are created and research is prepared to understand exactly what is needed in your app. During this phase of development, many things should be determined including: • The Target User of Your App—will it be the patient, a medical practitioner, your sales team • The Purpose of Your App—What function or service will your app provide to the user? Will it help to monitor medication dispensation? Will it track a patient’s progress? Does it help doctors and nurses control medical devices by a patient’s bedside? • What Features and Functionality Will the App Have?—More specifically, how will the app be used? Will it connect to devices outside of the mobile device such as a thermometer or a blood glucose meter? Will the app need to connect to an outside database? • How the App Will Work—What happens when the user opens the app? What screens will they look at? What buttons will the press? What happens when they press those buttons? • Is The App Safe?—As a medical product, the app will inevitably have some effect on the quality of care provided to the patient. Therefore, safety and reliability must be considered from the very beginning of the development project. • Why People Will Use the App?—What options do the users have? Why will they 100
Biomedical Instrumentation & Technology March/April 2015
Once you have determined everything above, it is important to layout the app similarly to how an architect would create the blueprints for a house. Building an app requires thought and serious attention to detail; this part of the development process will lay the foundation and set the tone for overall success of the app. 2. Design Thd design phase is generally broken out in to two parts, wireframing and design. During wireframing, all of the elements of the app are placed on the screen including placeholder images, text, buttons, and other necessary elements in black and white. This is done to give a general overview of what the app will look like before adding color and depth to the designs. After the wireframes are approved, designers will add color and depth using corporate branding guidelines or working from of an approved color palette. The design phase sees your app take shape, and will give you a great sense of how your app will look and feel. If preparations for marketing and branding your app have not begun yet, this is a great time to start that. 3. Development At this point, the backend of the app is created along with any hooks and connections to backend databases. While not as exciting as design, a properly developed application will create a bug-free and a pleasant user experience. 4. Testing For each application built, a custom testing plan is prepared, making sure that all elements of the application are tested and that all databases are properly connected. A thorough testing plan and execution strategy will help gain approval from Apple, the FDA, and your user base. Crashes and poorly performing applications will earn negative reviews and be highly detrimental to an app’s overall success.
© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
5. Deployment Once the app is ready for the spotlight, it is time to submit the app to Apple (for iOS apps), Google Play and other app stores (for Android Apps) or your own employees via servers and intranets (for corporate and enterprise apps). 6. Marketing and Promotion With any product, a well-drafted and executed marketing strategy will help ensure the success of a mobile application. Whether you have representatives visiting doctors’ offices to discuss the app with medical personnel or have your sales reps showing your customers how to use their new mobile application to control existing hardware devices, there are many different ways to market and promote your mobile app as an extension of your brand, and a new product which helps your customers.
Which Apps Need FDA Clearance? In a hearing in front of the Energy & Commerce Committee on March 21, 2013,5 the FDA emphasized that they are only looking to regulate a small subset of medical mobile applications. The agency has no intention of regulating the smartphone manufacturers, marketplaces (such as iTunes or Google Play), nor the majority of medical mobile apps that are used by consumers or healthcare providers; this is a very good thing as there are over 97,000 mHealth applications available in the major app stores today.3 The FDA initially issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on Sept. 25, 2013, and updated that guidance on Feb. 9, 2015. The guidance explains that the FDA’s oversight will focus on “apps that present a greater risk to patients if they don’t work as intended and on apps that cause Smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.” The guidance, originally issued as a draft on July 21, 2011, states that the FDA has jurisdiction over those apps that meet the definition of “device” in section 201(h) of the Federal Drug, Food, and Cosmetic Act (FD&C Act). Their main oversight will be the
The question of who the intended user is—patient, medical practitioner, or someone else—is a crucial consideration in deciding how to develop a medical app.
mobile medical apps that meet the above definition AND that are intended to: (1) be used as an accessory to a regulated medical device, or (2) transform a mobile platform into a regulated medical device. A type of app that would fall under FDA regulation oversight would include a mobile medical app that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or mobile tablet. Similarly, an app that turns a smartphone in to an electrocardiograph (ECG) machine to detect abnormal heart rhythms or to determine if a patient is having a heart attack would require FDA clearance as well. Applications that WOULD require FDA regulation include: • Apps that allow the user to view medical images on a mobile platform and perform an analysis or process for diagnosis
A type of app that would fall under FDA regulation oversight would include a mobile medical app that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or mobile tablet.
Biomedical Instrumentation & Technology March/April 2015
101
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Interesting to Note Not only does the functionality of your app determine whether it needs FDA clearance, but how you market your app matters. An app that uses a smartphone as a flashlight would not need FDA clearance unless it is marketed specifically as supporting a medical function, such as replicating an ophthalmoscope.
• Apps that analyze, assess, or interpret electrocardiogram or electroencephalogram data • Apps that connect the mobile platform to vital signs monitors, bedside monitors, cardiac monitors, or other similar devices • Apps that act as wireless remote controls or synchronization devices for MRI or X-ray machines • Apps that use a mobile platform’s built in features such as light, vibrations, camera, or other similar sources to perform medical functions • Apps that act as calculators or utilize algorithms to produce an index, score, scale, or other similar calculations (e.g., Glasgow Coma Scale, pain index, Apgar score, NIHstroke scale, etc.) • Apps that collect blood glucose readings and caloric intake to help manage diabetes by calculating pre-meal insulin dose (Bolus) or Basal adjustments For a full listing, view the September 2013 FDA Guidance, available to download at FDA. gov (www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf)
What does the FDA NOT Want to Regulate? It is important to understand what the FDA is not looking to regulate as well. The FDA’s proposed medical device-policy would not require mobile medical app developers to seek re-evaluation for minor, iterative product changes. Likewise, mobile apps that are used as an electronic or personal health record system would also not need clearance. Here is a list of types of apps that the FDA does not want to regulate:6 • Apps that are electronic copies of text books, teaching aids, or reference materials which do not contain any patient-specific information
The FDA’s proposed medical device-policy would not require mobile medical app developers to seek re-evaluation for minor, iterative product changes. Likewise, mobile apps that are used as an electronic or personal health record system would also not need clearance. 102
Biomedical Instrumentation & Technology March/April 2015
• Apps that are used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health or wellness • Apps which automate general office procedures such as billing, inventory, appointments, or insurance transactions • Apps that are generic aids that assist users but are not commercially marketed as a medical device • Apps that perform the functionality of an electronic health record system or personal health record system The FDA has been regulating medical device software for decades and has been reviewing mobile medical software for over ten years, their goal is to have a narrowly tailored, risk-based approach to regulating mobile medical apps. As of March 2013, the agency has reviewed approximately 100 mobile medical applications ranging from remote blood pressure, heart rhythm, and patient monitors to ultrasound, EKG, and glucose monitoring apps. The FDA states that they plan on creating a publicly available website with updated information and a list of mobile medical device apps that have been approved. For now, a partial list of approved apps can be found on the FDA website.
Overview of Mobile Medical Application FDA Regulatory Requirements Much of the information provided below is taken directly from the FDA.gov website section labeled “Device Advice.” This is a highly recommended resource to help you best understand and implement the appropriate FDA regulations for your mobile medical app. The most important step for the regulated app developer is determining the FDA “device classification” for your application. There are three classes of medical devices defined by the FDA – Class I, Class II and Class III. These are risk-based classifications, with Class I offering the lowest amount of risk, and Class III the highest. Depending on the determination of the FDA device classification for your app, some or all of the FDA regulations listed below may apply.
© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
1. Establishment Registration - 21 CFR Part 807 According to regulations, “manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Most establishments are required to pay an establishment registration fee.” 2. Medical Device Listing - 21CFR Part 807 By and large, Google and Apple won’t have to tangle with getting their actual app stores approved by the FDA. “Manufacturers must list their devices with the FDA. Establishments required to list their devices include the manufacturers of the mobile medical application, but in most cases do not include the distributor of the application, such as the Apple App Store or Google Play.” 3. Premarket Notification 510(k) - 21 CFR Part 807 Subpart E Most mobile medical apps are likely to be categorized by FDA regulations as a Class II medical device, which will require the submission of a Premarket Notification 510(k). Per administration rulings, “you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent.” Mobile medical apps that have been successfully reviewed by the FDA have been “cleared” for distribution in the U.S. 4. Premarket Approval (PMA) - 21 CFR Part 814 “Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.“ Mobile medical apps that have been successfully
reviewed by the FDA have been “approved” for distribution in the U.S. 5. Quality System Regulation (QS)/Good Manufacturing Practices (GMP) - 21 CFR Part 820 “The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.” For the mobile medical application developer, a key element of this regulation is Design Controls, 21 CR Part 820.30, which defines the types of controls and records that are required to ensure the device has been designed and developed to ensure that the device requirements are met. These requirements apply to the software development process for the app. 6. Labeling - 21 CFR Part 801 “Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device. “ This is an important set of regulatory requirements that define the types of labeling (such as splash screens, user guides, websites, marketing brochures, etc) that may be used for your specific app. It is vital to ensure that every aspect of your app and its associated marketing (up to and including social media posts) stay within regulatory guidelines. 7. Medical Device Reporting - 21 CFR Part 803 “Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported.” The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. This regulation applies to the mobile medical apps that have been cleared or approved by the FDA and have been distributed to users.
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8. Additional FDA Resources As noted above, the FDA.gov website has a large number of resources to help you understand and implement the specific FDA regulations required for your mobile medical app. Shown below are a few of the documents that are most helpful for app developers. • Draft Guidance for Industry and Food and Drug Administration Staff, Mobile Medical Applications Draft Guidance, July 21, 1011. • General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002. • Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. • www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ • List of Mobile Medical Apps the FDA has Cleared or Approved www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ConnectedHealth/MobileMedicalApplications/ucm368784.htm In closing, it is essential to note that creating a mobile application, whether it requires FDA clearance or not, requires a great deal of strategic planning, research and development in order to achieve success. The world of mobile app development is expanding at an exponential rate, and the FDA is doing what it can to balance the needs of regulation without hampering advancements in medical app technology. n
It is essential to note that creating a mobile application, whether it requires FDA clearance or not, requires a great deal of strategic planning, research and development in order to achieve success.
References 1. Portio Research. Fast growth of apps user base in booming Asia Pacific market. Available at: www.portioresearch.com/en/ blog/2013/fast-growth-of-apps-user-basein-booming-asia-pacific-market.aspx. Accessed April 28, 2014.
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2. Research2Guidance. 500m people will be using healthcare mobile applications in 2015. Available at: http://research2guidance. com/500m-people-will-be-using-healthcaremobile-applications-in-2015/. Accessed April 28, 2014. 3. Research2Guidance. (n.d.). Mobile Health Market Report 2013-2017. Retrieved from: www.research2guidance.com/shop/index. php/downloadable/download/sample/ sample_id/262/. 4. HIMSS Analytics. HIMSS Analytics Survey Demonstrates Widespread Use of Mobile Devices to Support Patient Care Activities. Available at: http://www. himssanalytics.org/about/NewsDetail. aspx?nid=81558. Accessed April 28, 2014. 5. U.S. House Energy & Commerce Committee. Health Information Technologies: Administration Perspectives on Innovation and Regulation. Available at: http:// energycommerce.house.gov/hearing/ health-information-technologies-administration-perspectives-innovation-and-regulation. Accessed April 28, 2014. 6. U.S. Food & Drug Administration. Mobile Medical Recommendations: 2013. 1st ed. Washington, DC: US Food & Drug Administration; 2013.
Features
Building a Mobile Medical App and Understanding FDA Regulatory Requirements Jason King
Smartphone adoption around the world is With the growing adoption of mobile rapidly growing with an estimated number of applications within the healthcare arena, the users at 1.2 billion in 2012 reaching 4.4 billion question arises: how exactly are apps develusers in 2017.1 In light of this widespread oped? More importantly, at what point does adoption of smartphones, many companies the FDA need to regulate your app, and how have been sent scrambling to take advantage do companies obtain FDA clearance? The of the new technology and build mobile aim of this article is to examine and explain applications that can help their clients, the development and deployment of medical employees, business partners, and managemobile apps from start to finish. ment team. In the world of healthcare, mobile medical How to Develop Medical apps can help consumers manage their own Mobile Applications health and wellness, promote healthy living, The most important thing to remember and gain useful information when and where when developing a mobile application is that they need it. Industry estimates show that you are in fact, creating a new product that 500 million smartphone users will be using a you are bringing to the market. As a medical healthcare application by this year,2 and by product, it will face the standard concerns of 2018, 50% of smartphone users will be using patient safety, user safety, and risk managea mobile medical app.3 ment. Whether the mobile app is a The Healthcare Information and Managestandalone product, works in conjunction ment Systems Society (HIMMS) released a with an existing product, or enhances a study in 2013 that showed the use of mobile service you provide, mobile applications need devices in hospitals and to be well researched, healthcare facilities is on planned out, and properly In the world of healthcare, the rise.4 In 2012, 45% of executed in order to be mobile medical apps can clinicians were using a effective. Always rememhelp consumers manage mobile device to collect ber that these mobile data at a patient’s bedside, their own health and applications are an an increase from 30% in extension of your brand. wellness, promote healthy 2011. Similarly, 34% of First we are going to go living, and gain useful those clinicians were moniover the steps involved in information when and toring patient data from creating a mobile applicawhere they need it. mobile devices, up from tion, and then we will 27% just a year before.4 take a look at which types
About the Author
Biomedical Instrumentation & Technology March/April 2015
Jason King is the president of Accella LLC. E-mail jason.king@ accella.net
99
© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
of apps need FDA clearance and how that process works.
choose to use your app over other mobile apps or other options outside of mobile applications?
The App Development Process There are six main steps in taking a mobile application from concept to creation; you will notice that many of these will mirror steps you would take while launching any product.
Building an app requires thought and serious attention to detail; this part of the development process will lay the foundation and set the tone for overall success of the app.
1. Strategy, Safety Requirements, Risk Management, and Architecture Phase During the initial stage of developing a mobile application, plans are created and research is prepared to understand exactly what is needed in your app. During this phase of development, many things should be determined including: • The Target User of Your App—will it be the patient, a medical practitioner, your sales team • The Purpose of Your App—What function or service will your app provide to the user? Will it help to monitor medication dispensation? Will it track a patient’s progress? Does it help doctors and nurses control medical devices by a patient’s bedside? • What Features and Functionality Will the App Have?—More specifically, how will the app be used? Will it connect to devices outside of the mobile device such as a thermometer or a blood glucose meter? Will the app need to connect to an outside database? • How the App Will Work—What happens when the user opens the app? What screens will they look at? What buttons will the press? What happens when they press those buttons? • Is The App Safe?—As a medical product, the app will inevitably have some effect on the quality of care provided to the patient. Therefore, safety and reliability must be considered from the very beginning of the development project. • Why People Will Use the App?—What options do the users have? Why will they 100
Biomedical Instrumentation & Technology March/April 2015
Once you have determined everything above, it is important to layout the app similarly to how an architect would create the blueprints for a house. Building an app requires thought and serious attention to detail; this part of the development process will lay the foundation and set the tone for overall success of the app. 2. Design Thd design phase is generally broken out in to two parts, wireframing and design. During wireframing, all of the elements of the app are placed on the screen including placeholder images, text, buttons, and other necessary elements in black and white. This is done to give a general overview of what the app will look like before adding color and depth to the designs. After the wireframes are approved, designers will add color and depth using corporate branding guidelines or working from of an approved color palette. The design phase sees your app take shape, and will give you a great sense of how your app will look and feel. If preparations for marketing and branding your app have not begun yet, this is a great time to start that. 3. Development At this point, the backend of the app is created along with any hooks and connections to backend databases. While not as exciting as design, a properly developed application will create a bug-free and a pleasant user experience. 4. Testing For each application built, a custom testing plan is prepared, making sure that all elements of the application are tested and that all databases are properly connected. A thorough testing plan and execution strategy will help gain approval from Apple, the FDA, and your user base. Crashes and poorly performing applications will earn negative reviews and be highly detrimental to an app’s overall success.
© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
5. Deployment Once the app is ready for the spotlight, it is time to submit the app to Apple (for iOS apps), Google Play and other app stores (for Android Apps) or your own employees via servers and intranets (for corporate and enterprise apps). 6. Marketing and Promotion With any product, a well-drafted and executed marketing strategy will help ensure the success of a mobile application. Whether you have representatives visiting doctors’ offices to discuss the app with medical personnel or have your sales reps showing your customers how to use their new mobile application to control existing hardware devices, there are many different ways to market and promote your mobile app as an extension of your brand, and a new product which helps your customers.
Which Apps Need FDA Clearance? In a hearing in front of the Energy & Commerce Committee on March 21, 2013,5 the FDA emphasized that they are only looking to regulate a small subset of medical mobile applications. The agency has no intention of regulating the smartphone manufacturers, marketplaces (such as iTunes or Google Play), nor the majority of medical mobile apps that are used by consumers or healthcare providers; this is a very good thing as there are over 97,000 mHealth applications available in the major app stores today.3 The FDA initially issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on Sept. 25, 2013, and updated that guidance on Feb. 9, 2015. The guidance explains that the FDA’s oversight will focus on “apps that present a greater risk to patients if they don’t work as intended and on apps that cause Smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.” The guidance, originally issued as a draft on July 21, 2011, states that the FDA has jurisdiction over those apps that meet the definition of “device” in section 201(h) of the Federal Drug, Food, and Cosmetic Act (FD&C Act). Their main oversight will be the
The question of who the intended user is—patient, medical practitioner, or someone else—is a crucial consideration in deciding how to develop a medical app.
mobile medical apps that meet the above definition AND that are intended to: (1) be used as an accessory to a regulated medical device, or (2) transform a mobile platform into a regulated medical device. A type of app that would fall under FDA regulation oversight would include a mobile medical app that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or mobile tablet. Similarly, an app that turns a smartphone in to an electrocardiograph (ECG) machine to detect abnormal heart rhythms or to determine if a patient is having a heart attack would require FDA clearance as well. Applications that WOULD require FDA regulation include: • Apps that allow the user to view medical images on a mobile platform and perform an analysis or process for diagnosis
A type of app that would fall under FDA regulation oversight would include a mobile medical app that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or mobile tablet.
Biomedical Instrumentation & Technology March/April 2015
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© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
Interesting to Note Not only does the functionality of your app determine whether it needs FDA clearance, but how you market your app matters. An app that uses a smartphone as a flashlight would not need FDA clearance unless it is marketed specifically as supporting a medical function, such as replicating an ophthalmoscope.
• Apps that analyze, assess, or interpret electrocardiogram or electroencephalogram data • Apps that connect the mobile platform to vital signs monitors, bedside monitors, cardiac monitors, or other similar devices • Apps that act as wireless remote controls or synchronization devices for MRI or X-ray machines • Apps that use a mobile platform’s built in features such as light, vibrations, camera, or other similar sources to perform medical functions • Apps that act as calculators or utilize algorithms to produce an index, score, scale, or other similar calculations (e.g., Glasgow Coma Scale, pain index, Apgar score, NIHstroke scale, etc.) • Apps that collect blood glucose readings and caloric intake to help manage diabetes by calculating pre-meal insulin dose (Bolus) or Basal adjustments For a full listing, view the September 2013 FDA Guidance, available to download at FDA. gov (www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf)
What does the FDA NOT Want to Regulate? It is important to understand what the FDA is not looking to regulate as well. The FDA’s proposed medical device-policy would not require mobile medical app developers to seek re-evaluation for minor, iterative product changes. Likewise, mobile apps that are used as an electronic or personal health record system would also not need clearance. Here is a list of types of apps that the FDA does not want to regulate:6 • Apps that are electronic copies of text books, teaching aids, or reference materials which do not contain any patient-specific information
The FDA’s proposed medical device-policy would not require mobile medical app developers to seek re-evaluation for minor, iterative product changes. Likewise, mobile apps that are used as an electronic or personal health record system would also not need clearance. 102
Biomedical Instrumentation & Technology March/April 2015
• Apps that are used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health or wellness • Apps which automate general office procedures such as billing, inventory, appointments, or insurance transactions • Apps that are generic aids that assist users but are not commercially marketed as a medical device • Apps that perform the functionality of an electronic health record system or personal health record system The FDA has been regulating medical device software for decades and has been reviewing mobile medical software for over ten years, their goal is to have a narrowly tailored, risk-based approach to regulating mobile medical apps. As of March 2013, the agency has reviewed approximately 100 mobile medical applications ranging from remote blood pressure, heart rhythm, and patient monitors to ultrasound, EKG, and glucose monitoring apps. The FDA states that they plan on creating a publicly available website with updated information and a list of mobile medical device apps that have been approved. For now, a partial list of approved apps can be found on the FDA website.
Overview of Mobile Medical Application FDA Regulatory Requirements Much of the information provided below is taken directly from the FDA.gov website section labeled “Device Advice.” This is a highly recommended resource to help you best understand and implement the appropriate FDA regulations for your mobile medical app. The most important step for the regulated app developer is determining the FDA “device classification” for your application. There are three classes of medical devices defined by the FDA – Class I, Class II and Class III. These are risk-based classifications, with Class I offering the lowest amount of risk, and Class III the highest. Depending on the determination of the FDA device classification for your app, some or all of the FDA regulations listed below may apply.
© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.
Features
1. Establishment Registration - 21 CFR Part 807 According to regulations, “manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Most establishments are required to pay an establishment registration fee.” 2. Medical Device Listing - 21CFR Part 807 By and large, Google and Apple won’t have to tangle with getting their actual app stores approved by the FDA. “Manufacturers must list their devices with the FDA. Establishments required to list their devices include the manufacturers of the mobile medical application, but in most cases do not include the distributor of the application, such as the Apple App Store or Google Play.” 3. Premarket Notification 510(k) - 21 CFR Part 807 Subpart E Most mobile medical apps are likely to be categorized by FDA regulations as a Class II medical device, which will require the submission of a Premarket Notification 510(k). Per administration rulings, “you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent.” Mobile medical apps that have been successfully reviewed by the FDA have been “cleared” for distribution in the U.S. 4. Premarket Approval (PMA) - 21 CFR Part 814 “Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.“ Mobile medical apps that have been successfully
reviewed by the FDA have been “approved” for distribution in the U.S. 5. Quality System Regulation (QS)/Good Manufacturing Practices (GMP) - 21 CFR Part 820 “The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.” For the mobile medical application developer, a key element of this regulation is Design Controls, 21 CR Part 820.30, which defines the types of controls and records that are required to ensure the device has been designed and developed to ensure that the device requirements are met. These requirements apply to the software development process for the app. 6. Labeling - 21 CFR Part 801 “Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device. “ This is an important set of regulatory requirements that define the types of labeling (such as splash screens, user guides, websites, marketing brochures, etc) that may be used for your specific app. It is vital to ensure that every aspect of your app and its associated marketing (up to and including social media posts) stay within regulatory guidelines. 7. Medical Device Reporting - 21 CFR Part 803 “Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported.” The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. This regulation applies to the mobile medical apps that have been cleared or approved by the FDA and have been distributed to users.
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8. Additional FDA Resources As noted above, the FDA.gov website has a large number of resources to help you understand and implement the specific FDA regulations required for your mobile medical app. Shown below are a few of the documents that are most helpful for app developers. • Draft Guidance for Industry and Food and Drug Administration Staff, Mobile Medical Applications Draft Guidance, July 21, 1011. • General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002. • Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. • www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ • List of Mobile Medical Apps the FDA has Cleared or Approved www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ConnectedHealth/MobileMedicalApplications/ucm368784.htm In closing, it is essential to note that creating a mobile application, whether it requires FDA clearance or not, requires a great deal of strategic planning, research and development in order to achieve success. The world of mobile app development is expanding at an exponential rate, and the FDA is doing what it can to balance the needs of regulation without hampering advancements in medical app technology. n
It is essential to note that creating a mobile application, whether it requires FDA clearance or not, requires a great deal of strategic planning, research and development in order to achieve success.
References 1. Portio Research. Fast growth of apps user base in booming Asia Pacific market. Available at: www.portioresearch.com/en/ blog/2013/fast-growth-of-apps-user-basein-booming-asia-pacific-market.aspx. Accessed April 28, 2014.
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2. Research2Guidance. 500m people will be using healthcare mobile applications in 2015. Available at: http://research2guidance. com/500m-people-will-be-using-healthcaremobile-applications-in-2015/. Accessed April 28, 2014. 3. Research2Guidance. (n.d.). Mobile Health Market Report 2013-2017. Retrieved from: www.research2guidance.com/shop/index. php/downloadable/download/sample/ sample_id/262/. 4. HIMSS Analytics. HIMSS Analytics Survey Demonstrates Widespread Use of Mobile Devices to Support Patient Care Activities. Available at: http://www. himssanalytics.org/about/NewsDetail. aspx?nid=81558. Accessed April 28, 2014. 5. U.S. House Energy & Commerce Committee. Health Information Technologies: Administration Perspectives on Innovation and Regulation. Available at: http:// energycommerce.house.gov/hearing/ health-information-technologies-administration-perspectives-innovation-and-regulation. Accessed April 28, 2014. 6. U.S. Food & Drug Administration. Mobile Medical Recommendations: 2013. 1st ed. Washington, DC: US Food & Drug Administration; 2013.
