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Mobile Apps in Healthcare
Mobile Apps in HealthcarePart 2: Developing an FDA-Regulated App
Jack Ward, Senior Director, Myraqa Inc. Dylan Reinhardt, COO, Myraqa Inc.
Overview of this Presentation1. FDA Regulatory Background for Mobile Medical Apps2. Current Status of Mobile Medical Apps 3. Software Lifecycle for Medical Mobile Apps4. Mobile Medical App Developer QSR Compliance - Legal and Technical Challenges5. Appendix - Example List of FDA 510(k) Cleared Mobile Medical Applications
FDA’s Authority• 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
• Medical device companies refer to this regulation as the QS Reg, QSR, GMPs or cGMPs.
• Given the rapid expansion and broad applicability of mobile apps, the FDA has issued a draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority:• Draft Guidance for Industry and Food and Drug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
Key Points of FDA Testimony• 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.
• 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.
Key Points of FDA Testimony• The FDA has been regulating medical device software for
decades and medical device software on mobile platforms for more than 10 years. This means that many current FDA guidances, regulations and recognized standards for medical device software are available.
• 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
Definition of Medical Device• Does your app meet the FDA’s definition of
medical device?• Related elements from Section 201(h) of the
Federal Food, Drug and Cosmetic Act (FD&C Act) define medical device as:
“…an instrument, apparatus, implement, machine,contrivance, implant, in vitro reagent, or other similar orrelated article, including any component, part or accessory,which is …Intended for use in the diagnosis of disease orother conditions, or in the cure, mitigation, treatment, orprevention of disease, in man or other animals…..”
Definition of Medical Device• FDA “Warning Letters” to industry often contain
the text “The FDA has determined that your firm manufactures xxx…..Under section 201(h) of the Food, Drug and Cosmetic Act, these products are devices….
• If an app developer promotes an app in a manner that meets the definition of device, then the FDA regulations will apply.
• “Promotion” can be in the form of a website, advertising brochures, industry presentations, instructions for use, or verbal communications.
Note: Items with * can be searched at FDA.gov for additional information.
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
1 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.
iPhoneOperating System Platform
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.
Initial Assumptions for this App1. Class II device – 510(k) submission required.2. GMP exempt? No. (QS/GMP regulation applies).3. Developer implements QS coincident with app. 4. SW App only - No additional hardware required.5. Special Controls/Recognized Standards apply.6. Runs only on iPhone, iTouch and iPad.7. Distributed through the Apple “App Store”.8. App developer is U.S. based.
Examples of apps that might match the above criteria: Audiometer,dosage calculator, image viewer, medical camera…. See appendix.
Initial Quality System Manual, SOPs & Quality PlanA
DELIVERABLE COMMENTS1. Initial Quality System Manual
For a simple device and small company, the initial Quality System may be documented in a 20+ page Quality Manual that defines how the requirements of GMP will be met. Suggested elements of 21 CFR Part 820 to be implemented initially include: a) Management Responsibility: Quality Policy,
Organization, Resources, Management Representative, Management Review, Audits, Personnel and Training.
b) Document Controls: The process and responsibilities for developing, reviewing, approving, distributing and documenting changes to the documents you develop to establish the GMP Quality System.
Initial Quality System Manual, SOPs & Quality PlanA
DELIVERABLE COMMENTS2. SOPs a) SOPs (Standard Operating Procedures) are the
documented procedures you will define, document and implement to ensure your Quality System is compliant with the GMPs. For a simple device and a small company, the SOP instructions may be included as part of the Quality Manual – otherwise, there will be separate documents (SOPs) for each required element of the GMPs. For example, the training requirements for the company may be documented in a Training SOP or defined within the Quality Manual.
b) The Quality Manual should contain a table that lists all the SOPs, and any lower level documents such as Work Instructions.
Initial Quality System Manual, SOPs & Quality PlanA
DELIVERABLE COMMENTS3. Quality Plan a) For a simple device and a small company,
implementing all the required elements of the GMPs (21 CFR Part 820) can best be managed through a phased approach, establishing the QS elements sequentially as required to support your product development process and the compliance/regulatory requirements of your device type.
b) An approved Quality Plan, as a formal Quality System document, is the suggested approach for establishing the Quality System implementation sequence, deliverables and owners.
a) Defines the timing, responsibilities, and deliverables required for FDA interaction.
b) Key deliverables include determination of device classification, Product Code, intended use/labeling, and Substantial Equivalence to currently cleared devices.
Use these references (both at FDA.gov):
“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
Final Elements of Quality System Implemented DELIVERABLE COMMENTS
1. Final Revision of Quality System Manual and SOPs
a) The initial Quality System Manual that was established, with the Quality Plan, to establish a Quality System appropriate for your company and device should now be reviewed, updated and finalized. This Manual, and the Quality System, will be the basis for your ongoing development and support of the mobile medical app, including updates.b) The remaining SOPs identified in the Quality Plan as required for the Quality System should be finalized. These include QS elements such as Purchasing Controls, Nonconforming Product, CAPA, Complaint Handling, and Production and Process Controls as required, including Identification/Traceability, Acceptance, Labelling/Packaging, Handling, Storage, Distribution and Statistical Techniques.
DELIVERABLE COMMENTS2. Quality Plan a) The Quality Plan that was established for the
phased implementation of the Quality System should now be reviewed and finalized, to document that the plan was followed and that the results are compliant with the GMPs. It is common to conduct an external audit, by a qualified 3rd party, to assess GMP compliance. b) A “Post-Distribution” Quality Plan should be established at this time, to formally document the expected quality goals and processes for the app after release for customer use.
DELIVERABLE COMMENTS1. Additional FDA regulatory requirements
a) 21 CFR Part 807 - Establishment Registration and Device Listing
- Within 30 days of initial device distribution in U.S.- Annual renewal
b) 21 CFR Part 803 – Medical Device Reporting (for Adverse Events)
- Within 30 calendar days of becoming aware of a complaint of device malfunctions associated with death or serious injury (Within 5 working days if the device malfunction is the subject of a recall)
DELIVERABLE COMMENTS3. Additional FDA regulatory requirements
a) Guidance – Deciding When to Submit a 510(k) for a Change to an Existing Device
- Specific types of changes to an existing device may require a new 510(k) prior to distributing. Examples of changes for the App that might require a new 510(k):
- Change to intended use (Home use vs Health facility use)
- Change in technology (New sensor type for oxygen level measurement)
• By revenues, Apple is one of the 20 largest companies in the world and the only one selling software
• By market cap, Apple was the largest company in the world through 2012; they have been in the top 3 since Q2 2010, when they overtook Microsoft
• The App Store is the golden goose at Apple and is very tightly managed
• Apps that support Apple’s goals (enhancing the platform) will do far better than those that don’t
• Apple’s primary concern is for the value of the platform, not your QSR needs; what is good policy for Facebook or Angry Birds will shape the world you need to live in
• Revenues: Apple always gets 30% off the top• Review criteria
• General app quality, conformance to platform standards
• Support for specific iOS devices, configurations• Apps may rely on iOS functionality, but in most cases
may not duplicate it or compete with it• Apps held to Human Interface Guidelines and Apple’s
somewhat inscrutable marketing goals, e.g.: “…need to provide a beautiful, custom app icon that people will enjoy seeing in the App Store and on their Home screens”
• Typically, individual device owners purchase apps using their personal iTunes accounts
• Volume Purchasing Program exists for centralized purchasing, not a major channel yet
• Apple makes a point of providing• Consistency (of user experience)• Security (between apps)• Reusability (of credit card)• Privacy (from app developer, other 3rd parties)
• Without having a direct relationship, how is the developer supposed to meet their QSR responsibilities to their customers?
• App-specific solutions• Provide link / tool for complaints / support• Narrow scope of app to “viewer” for actual service• Require direct account to enable / unlock regulated
features or content• Lock / restrict app if available update not applied• Encourage voluntary provision of email address to
communicate updates, recalls• Use push notifications (can be disabled by user)
4. This presentation has provided specific examples of mobile medical apps, “CFR regulations”, “Product Code” and TLPC information available at FDA.gov which can be used by the developer during regulatory and QS planning for the app. 5. A complete example of a Mobile Medical App phased development process has been presented, which includes these following elements: Initial QS/Quality Manual/Plan, Design Control, 510(k) submission, Final QS implementation, and Post Market requirements.
6. Comments regarding the business and regulatory responsibilities for developers, the App Store, and Health Care providers have been presented, with an overall conceptual model for developer review. 7. An Appendix has been included with this presentation, which documents multiple examples of current 510(k)-cleared Mobile Medical Apps. This is an informational resource for Mobile Medical App developers.
EXAMPLE LIST OF FDA 510(k) CLEARED MOBILE MEDICAL APPLICATIONS (May 16, 2013)
Introduction: This list has been developed from publicly availableinformation at fda.gov, and is intended for educational purposes only.This is not intended to be a complete list, as the available information isfrequently updated. Note also that corporate and proprietary productnames aren’t included – this additional information can be accesseddirectly at fda.gov from the information provided.
The device is an attachment and software used onlywith the iPhone 4 and iPhone 4S in conjunction with theOpthalmoscope to allow users to capture, send, storeand retrieve images of the eye. The device is intendedto be used by trained personnel within a medical orschool environment.
iPhone 4iPhone 4S
2 K122356 Nov 19, 2012
DPS – 870.2340 Electrocardiograph
A heart monitor intended for use by licensedprofessionals or patients to record, display, store andtransfer single-channel electrocardiogram (ECG)rhythms.
iPhone
3 K122136 Sep 7, 2012 LLZ – 892.2050Picture Archiving and Communications System
The device is a medical image viewing and informationdistribution application that provides access, throughthe internet and within the enterprise, to multi-modalitysoftcopy medial images, reports and other patient-related information, that may be hosted within disparatearchives and repositories for review, communicationand reporting of DICOM and non-DICOM data. Thedevice is not intended for primary diagnosis. Whenaccessed from a mobile tablet, the device is forinformational purposes only and not intended fordiagnostic use.
The App is intended to be used to aid current clinicalpractices in recording the number of surgical spongesand for visibility for assessment of sponge images. TheApp is intended to be used in the Operating Theatre toassist users with sponge management practices byproviding another method to visually capture and displayimages of used sponges using software running on aniPad mobile platform.
iPad
5 K121165 Jun 21, 2012
EFW – 872.6855Manual Toothbrush(Class I)
The device is a toothbrush to remove plaque and debrisfrom its user’s teeth and aide in the prevention of toothdecay. The device collects brushing usage data andwirelessly transmits the data to a software application(App) that runs on the user’s own mobile device(“smartphone”).
The application is intended for use in the homeand professional settings to aid individuals withdiabetes and their healthcare professionals: in thereview, analysis and evaluation of blood glucosetest results to support an effective diabetesmanagement program. It is an optional datamanagement software accessory for use with theblood glucose meter with a mini-USB port.. Theapplication allows users to download bloodglucose reading automatically from the meter toan iPhone Operating System platform.
iPhone Operating System platform
7 K110872 May 20, 2011Corrected on Jul 18, 2011
DXN – 870.1130Non-invasive Blood Pressure Monitoring System
Description of the device: The blood pressuremonitor, upper arm type, uses the Oscillometricmethod to measure the blood pressure. TheOscillometric method is adopted clinically tomeasure the blood pressure recently. It is notneeded to use the stethoscope, as in thetraditional measuring method, to monitor theKorotkov sound when deciding the systolic ordiastolic pressure. This device can connect toiPhone.
LLZ – 892.2050Picture Archiving and Communications System
The mobile software program is used to displaymedical images for diagnosis from CT and MRImodalities only. It provides wireless and portableaccess to medical images. This device is notintended to replace full workstations and shouldbe used only when there is no access to aworkstation. This device is not to be used formammography.
Apple IOS and iPad
9 K103785 Feb 4, 2011
LLZ – 892.2050Picture Archiving and Communications System
The mobile software program is used for theregistration, fusion, and/or display for diagnosis ofmedical images from only the followingmodalities: SPECT, PET, CT, and MRI. Thedevice provides wireless and portable access tomedical images. This device is not intended toreplace full workstations and should be used onlywhen these is no access to a workstation. Thisdevice is not to be used for mammography.
The Balance System is intended for use toassess sway as an indicator of balance.Individual suitability for assessment must bejudged on a case by case basis, by a qualifiedindividual including those certified and/or licensedin their state to prescribe and/or use balancedevices such as certified athletic trainers andcoaches, physical therapists, nurses andphysicians. Conditions affecting postural swayinclude nausea, headache, orthopedic injury, earinfection, medications, head injury, dehydration,and fatigue. The Balance System can be usedwherever an iOS mobile operating device isavailable.
iOS mobile operating system and iPhone 3G, 3GS, 4, 4S, iPad, iPad2, and iPod Touch.
DXN – 870.1130Non-invasive Blood Pressure Monitoring System
The Fully Automatic Arm Cuff Blood PressureDock is for use by medical professionals or athome and is a non-invasive blood pressuremeasurement system intended to measure thediastolic and systolic blood pressures and pulserate of an adult individual by using a non-invasivetechnique in which an inflatable cuff is wrappedaround the upper arm. Device Description: For itdoes not contain an LCD or other displaycomponents, so it’s necessary for the device tocomment to an iPhone, iPod or iPad containing asupport software to constitute a complete bloodpressure measurement system.
The Cardiac Rhythm Monitor is intended for useby patients who may experience transientsymptoms that could suggest cardiac arrhythmia.The device records the patients ECG on demandat any time the patient feels any physicalsymptom indicative of a potential heart event.Device Description: The recorded ECG data canbe transferred to mobile phone using micro USBcable/30-pin cable provided. The ECG then canbe transmitted via cellular link or WiFi to anInternet depository when the patient ECG recordsare filed. The Internet depositories compatiblewith the device can be accessed via designatedwebsites. The compatible smart cell/mobilephones that can upload ECG records from thedevice include iPhone, Blackberry, Symbian andsmart phones running on Android. These mobilephones will require to install the Uploader App -the user can easily download the Apps from AppWorld, Android Market, etc. and install it.
iPhone, Blackberry,Symbian, and smart phones running on Android.
The WiFi Body Scale is indicated to measurebody weight, estimate body fat, body waterpercentage, body muscle mas, bones mas,visceral fat rating, and daily calorie intake (DCI)using BIA (bioelectrical impedance analysis).Device Description: The patient steps on thescale device, where four electrodes are located.The patient must step on the electrodes with barefeet, with normal moisture. This calculation isdone via the Bioelectrical Impedance Method.The calculation is based upon electricalimpedance, height, weight, age and gender. Thecalculation is performed via internal software,which uses variables programmed in by the user.WiFi body scale can be used with an iPod Touch,iPhone or iPad.
Device Description: The Arrhythmia DiagnosticSystem is an ambulatory ECG monitor whichanalyzes electrographic signal, classifies alldetected heart beats and recognizes rhythmabnormalities. All detection results aretransmitted via cellular telephony network to aremote server accessible by a Monitoring Centerfor reviewing by trained medical staff. The patientworn transmitter streams via Bluetooth link thesignal to a Windows Mobile or Android OSoperated PDA. The PDA runs proprietarysoftware which produces QRS annotations andmanages data transmission.
HGM – 884.2740Perinatal Monitoring System and Accessories
The device is a software-only application intendedfor use on iOS devices by obstetrical healthcareclinicians to view near real time the simultaneousmeasurement of fetal heart rate(s) and uterinecontractions waveforms in one view. The devicetransforms the ongoing measurements into avisual wave display which conveys the frequency,duration and relative strength of uterinecontractions combined with the patient data ofpatient data of pregnant women in the antepartumand/or intrapartum phases of pregnancy.