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Mobile Apps in Healthcare
Mobile Apps in HealthcarePart I: Developing an Educational App
Jack Ward, Senior Director, Myraqa Inc. Jason King, President and CEO, Accella
• The FDA has legal authority to regulate medical devices, defined primarily in the “Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule: Quality System Regulation” – 21 CFR Part 820
• Additional key FDA regulations may also apply: • Part 801 (Labeling)• Part 803 (Reporting)• Part 806 (Corrections and Removals)• Part 807 (Registration and Listing)• And others
• Given the rapid expansion and broad applicability of mobile apps, the FDA has issued a draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority:• Draft Guidance for Industry and Food and Drug
Administration Staff, Mobile Medical Applications, July 21, 2011
The FDA has recently provided testimony to Congress regarding assessment and regulatory status of mobile medical appsStatement of Christy L. Foreman, Director, Office of Device Evaluation, Center for Devices and Radiological Health, Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, “Health Information Technologies: Administration Perspectives on Innovation and Regulation”, March 21, 2013
• Industry estimates that 500 million smartphone users worldwide will be using a health care application by 2015. These users include health care professionals, consumers, and patients.
• FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation, assuring appropriate patient protections.
• FDA recognizes that mobile health application developers and manufacturers need a clear, predictable, and reasonable understanding of the Agency’s expectations.
• The Agency intends to maintain a publicly available website with information listing those apps which have been cleared or approved by FDA and those for which FDA will exercise enforcement discretion.
• The FDA has been regulating medical device software for decades and medical device software on mobile platforms for more than 10 years.
• To date the FDA has reviewed approximately 100 mobile medical apps, including remote blood pressure, heart rhythm, and patient monitors, and smartphone-based ultrasounds, EKG machines, and blood glucose monitors.
• In the Draft Guidance, the FDA has provided the following definition for a mobile medical app:
• A mobile app that meets the definition of “device” in section 201(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and either • is used as an accessory to a regulated device; or• transforms a mobile platform into a regulated medical
device • The Intended Use of a mobile app determines
The device is an attachment andsoftware used only with theiPhone 4 and 4S in conjunctionwith the Opthalmoscope to allowusers to capture, send store andretrieve images of the eye. Thedevice is intended to be used bytrained personnel within a medicalor school environment.
Note: Items with * can be searched at FDA.gov for additional information.
Mobile Apps in Healthcare
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
2 K122356*
ClearanceDate
Nov 19, 2012
DPS*870.2340*
Electrocardiograph
A heart monitor intended for useby licensed professionals orpatients to record, display, storeand transfer single-channelelectrocardiogram ECG rhythms.
Note: Items with * can be searched at FDA.gov for additional information.
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
3 K101597*
ClearanceDate
Oct 18, 2010
NBW/JQP*862.1345*
Glucose Test System
The application is intended for usein the home and professionalsettings to aid individuals withdiabetes and their healthcareprofessionals: in the review,analysis and evaluation of bloodglucose test results to support aneffective diabetes managementprogram. The application allowsusers to download blood glucosereading automatically from themeter to an iPhone OperatingSystem Platform.
Note: Items with * can be searched at FDA.gov for additional information.
Mobile Apps in Healthcare
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
4 K121590*
ClearanceDate
Sep 20, 2012
LXV*Unclassified
Vestibular Analysis Apparatus
“Sway BalanceTM”
The Sway BalanceTM System isintended for use to assess sway asan indicator of balance. Individualsuitability for assessment must bejudged on a case by base basis,by a qualified individual includingthose certified and/or licensed intheir state to prescribe and/or usebalance devices such as certifiedathletic trainers and coaches,physical therapists, nurses andphysicians.
Note: Items with * can be searched at FDA.gov for additional information.
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
5 K121165*
ClearanceDate
Jun 21, 2012
EFW*872.6855*
Manual Toothbrush(Class I)
The device is a toothbrush toremove plaque and debris from itsuser’s teeth and aide in theprevention of tooth decay. Thedevice collects brushing usagedata and wirelessly transmits thedata to a software application(App) that runs on the user’s ownmobile device (“smartphone”).
Note: Items with * can be searched at FDA.gov for additional information.
Mobile Apps in Healthcare
Categories of Mobile Medical Apps
1. Mobile apps that are extensions of regulated medical device for the purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data. (Example – mobile platform functionality to control inflation and deflation of a blood pressure cuff)
2. Mobile apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions. (Example – attachment of a transducer to a mobile platform to function as a stethoscope)
3. Mobile apps that allow the user to input patient-specific information and - using formulae or a processing algorithm - output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions. (Example – calculate dosage for a specific medication or radiation treatment)
1. Mobile apps that are electronic “copies” of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received. (Example – slideshow of common conditions)
2. Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. (Example – dietary tracking logs)
3. Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions. (Example – determining billing codes like ICD-9)
4. Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication. (Examples – audio recording or note taking)
5. Mobile apps that perform the functionality of an electronic health record system or personal health record system.
Categories of Mobile Non-Medical Apps as shown above are discussed, with examples, in “Draft Guidance for Industry and Food and Drug Administration Staff, Mobile Medical Applications, July 21, 2011
1. The FDA has indicated that it intends to apply its regulatory requirements solely to a subset of mobile apps it is calling “mobile medical apps.”
2. The FDA has been regulating medical device software for decades and medical device software on mobile platforms for more than 10 years.
3. To date the FDA has reviewed approximately 100 mobile medical apps, including remote blood pressure, heart rhythm, and patient monitors, and smartphone-based ultrasounds, EKG machines, and blood glucose monitors.
FDA Regulatory Summary4. This presentation has provided specific examples of
mobile medical apps that have been cleared by the FDA. The examples include highlighted “search items” to allow for detailed review at FDA.gov.
5. In addition, this presentation has provided references and extended discussion of the current FDA draft guidance that should be the basis for determining the FDA regulatory requirements for a specific mobile app.
6. The remainder of this webinar will outline the process for creating an app when FDA involvement is not required. Part II of the webinar series on May 16 will further define the development of FDA-regulated mobile medical apps.