Mobile Apps in Healthcare - Platformaami.confedge.com/asset/confEdge/aami/_warehouse/files/... ·...

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Mobile Apps in Healthcare Mobile Apps in Healthcare Part 2: Developing an FDA-Regulated App Jack Ward, Senior Director, Myraqa Inc. Dylan Reinhardt, COO, Myraqa Inc. 5/16/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 1 Overview of this Presentation 1. FDA Regulatory Background for Mobile Medical Apps 2. Current Status of Mobile Medical Apps 3. Software Lifecycle for Medical Mobile Apps 4. Mobile Medical App Developer QSR Compliance - Legal and Technical Challenges 5. Appendix - Example List of FDA 510(k) Cleared Mobile Medical Applications 5/16/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 2

Transcript of Mobile Apps in Healthcare - Platformaami.confedge.com/asset/confEdge/aami/_warehouse/files/... ·...

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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.

5/16/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 1

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

5/16/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 2

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Mobile Apps in Healthcare

FDA Regulatory Background for Mobile Medical Apps

Jack Ward

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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.

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Mobile Apps in Healthcare

Draft Guidance Document

• Given the rapid expansion and broad applicability of mobile apps, the FDA has issued a draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority:• Draft Guidance for Industry and Food and Drug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

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Applicability of Guidance Document

• At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps it is calling “mobile medical apps”

• FDA “guidance” is not legally enforceable, but provides the Agency’s current thinking

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Mobile Apps in Healthcare

Current FDA Status

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

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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.

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Mobile Apps in Healthcare

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.

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Definition of Mobile Medical App

• 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

whether it meets the definition of a “device”

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Mobile Apps in Healthcare

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…..”

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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.

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Mobile Apps in Healthcare

Examples of Mobile Medical Apps

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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.

iPhone

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Note: Items with * can be searched at FDA.gov for additional information.

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Mobile Apps in Healthcare

Example of Mobile Medical App - Regulation

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Screen capture from FDA.gov of Electrocardiograph regulation – 21 CFR 870.2340

Example of Mobile Medical App - Prod Code

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Partial screen capture from FDA.gov of Product Code DPS

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Mobile Apps in Healthcare

Example of Mobile Medical App - TPLC

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Partial screen capture from FDA.gov of Product Code DPS - TPLC

Example of Mobile Medical App - TPLC

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Partial screen capture from FDA.gov of Product Code DPS - TPLC

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Mobile Apps in Healthcare

Developing a Mobile Medical App – Initial Planning

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Determine Regulatory andQS/Development Requirements

(Use FDA.gov to review Product Codes, Device Regulations and Guidances)

1. Intended Use2. Class I, II, III3. Substantially

Equivalent Devices (510K)

1. GMP Exempt?2. Special Controls &

Recognized Standards

Regulatory Requirements

QS/Development Requirements

Example of Mobile Medical App Development Lifecycle

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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.

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App Development Lifecycle

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Example ofMobile Medical App

Development Lifecycle

510(k)Submitted

To FDA

Initial Quality System Manual, SOPs &

Quality Plan

Design Control Implemented

App SW Developed, Tested,

and Finalized

510(k)Clearedby FDA

Design History File Completed

Final Elementsof Quality System

Implemented

App Released by Apps Store

Initial QualitySystem Elements

Implemented PostMarket

B

C

D

E

A

App Development Phases

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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.

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App Development Phases

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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.

App Development Phases

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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.

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Mobile Apps in Healthcare

App Development Phases

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Design Control Implemented

DELIVERABLE COMMENTS1. Design Control SOP

a) Outline of the complete development process – for SW only device, can be in the form of a Software Development Lifecycle - SDLC.

Use these references:

“General Principles of Software Validation; Final Guidance for Industry and FDA Staff” – at FDA.gov

“Medical device software – Software life cycle processes” – ANSI/AAMI/IEC 62304:2006

B

App Development Phases

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Design Control ImplementedDELIVERABLE COMMENTS

2. Design Control Deliverables for Software

a) Design Control Procedures(SDLC – Software Development Lifecycle)

b) Design and Development Planning(Software Plan/Software Quality Plan)

c) Design Input(Software Requirements)

d) Design Output(Software Design Specs, Source Code, Executables)

e) Design Review(Independent Review)

B

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App Development Phases

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Design Control ImplementedDELIVERABLE COMMENTS

2. Design Control Deliverables for Software

f) Design Verification(Testing by Developer)

g) Design Validation & Risk Analysis(User Site Testing & Preliminary and UpdatedRisk Files)

h) Design Transfer(Production Processes Defined and Implemented)

i) Design Changes(Maintenance and Software Changes)

j) Design History File(Defined Software Design History Records)

B

App Development Phases

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510(k) Submitted to the FDA

DELIVERABLE COMMENTS1. Regulatory Plan

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”

“Off-The-Shelf Software Use in Medical Devices”

C

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App Development Phases

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510(k) Submitted to the FDA

DELIVERABLE COMMENTS2. Key Submission Requirements for Class II device containing software

a) Determine Level of Concern (LOC)b) Software Descriptionc) Device Hazard Analysisd) SW Requirements Specificationse) Architecture Design Chartf) Software Design Specificationg) Traceability Analysish) Software Development Environment Descriptioni) Verification and Validation Documentationj) Revision Level Historyk) Unresolved Anomalies

C

App Development Phases

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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.

D

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App Development Phases

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Final Elements of Quality System Implemented

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.

D

App Development Phases

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Post Market

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)

E

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App Development Phases

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Post Market DELIVERABLE COMMENTS

2. Additional FDA regulatory requirements

a) 21 CFR Part 806 – Reports of Corrections and Removals

- Requires reporting to FDA and possible voluntary or mandatory Recall for specific types of updates to the product

- What about IOS updates? App updates?

b) FDA Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-shelf (OTS) Software

- Current FDA best thinking on regulatory requirements for updating OTS software (IOS for example) to address security concerns (viruses)

- App developer required to establish and maintain a software maintenance plan

E

App Development Phases

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Post Market

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)

E

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App Development Phases

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Example ofMobile Medical App

Development Lifecycle

510(k)Submitted

To FDA

Initial Quality System Manual, SOPs &

Quality Plan

Design Control Implemented

App SW Developed, Tested,

and Finalized

510(k)Clearedby FDA

Design History File Completed

Final Elementsof Quality System

Implemented

App Released by Apps Store

Initial QualitySystem Elements

Implemented PostMarket

B

C

D

E

A

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Mobile Medical App Developer QSR Compliance - Legal and

Technical ChallengesDylan Reinhardt

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Medical App Distribution

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Mobile Medical AppDeveloper

APPLE Store

Health CareProvider

Commercial Agreement

Commercial Agreement

???

Regulatory Responsibilities

Medical App DistributionThe Rules of the Game

• 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

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Medical App Distribution

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Mobile Medical AppDeveloper

APPLE Store

Commercial Agreement

Medical App DistributionDeveloper – App Store

• App developers must register for Apple Developer Program

• Apps must be coded in Objective C, but can be “thin” clients or consist of little more than configured browser instances

• Apps can be deployed • Ad hoc (limited quantities)• Through Enterprise App Store (“employees” only)• Through Volume Purchase Program (special

licensing)• Through Apple App Store (requires Apple review)

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Medical App DistributionDeveloper – App Store

• 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”

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Medical App Distribution

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APPLE Store

Health CareProvider

Commercial Agreement

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Mobile Apps in Healthcare

Medical App DistributionHC Provider – App Store

• 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)

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Medical App Distribution

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Health CareProvider

???

Regulatory Responsibilities

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Mobile Apps in Healthcare

Medical App DistributionDeveloper – HC Provider

• Under QSR, a device manufacturer has regulatory responsibility to the device purchaser

• Under the App Store model• Buyers have an expectation that their private information is

not shared with the app developer• Developers can not see almost anything about their users;

not even able to collect UDIDs that could “track” users app to app

• Users provide app feedback to Apple by “rating” an application

• Developers see what the general public sees, they are not able to follow up directly with review submitters

• Case study: turbofrog4837 gives your X-Ray viewer app 2 stars and says it caused their cousin to suffer seizures. Now what?

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Medical App DistributionDeveloper – HC Provider

• 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)

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Medical App DistributionDeveloper – HC Provider

• General QSR solutions• Provide contact phone, email, address for complaints• Monitor what is said about your device in public

forums (App Store, Facebook, Twitter, etc.)• What about Google Play and Microsoft Store?

• Control of apps is less defined – for now• The FDA has committed to publishing the final

guidance on Mobile Medical Apps by Q4 2013• App developers should review to determine FDA best

thinking on responsibilities of app developers, “stores” and end users

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Summary of Key PointsMobile Apps in Healthcare

Part 2: Developing anFDA-Regulated App

Jack Ward

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Mobile Medical App Summary

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. This means that many current FDA guidances, regulations and recognized standards for medical device software are available. 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.5/16/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 49

Mobile Medical AppSummary

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.

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Mobile Medical AppSummary

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.

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52

Questions?

Or press *1 on your telephone keypad

Type your question in the Q&A box on the left side of your screen and press Enter

5/16/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org

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Mobile Apps in Healthcare

Closing Reminders

• Please be sure to fill out the evaluation form at: http://aami.confedge.com/ap/survey/s.cfm?s=Mobile2

• Other webinars that might be of interest to you:• June 6: House of Quality / Quality Function

Deployment: A Key Toolset for Design Control • June 14: Combination Products: Understand and

Implement the Requirements• September 17: Selling HF: The Business Case for

Human Factors in Industry

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Appendix

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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.

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Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for Use Mobile Platform

1 K121405 Dec 20, 2012

HKI - 886.1120Opthalmic Camera

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.

Various IOS and Android tablet devices

Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for Use Mobile Platform

4 K120473 Apr 9, 2012 LWH - 880.2740Surgical Sponge Counter(Class I)

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”).

Bluetooth‐enabledphone 

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for Use Mobile Platform

6 K101597 Oct 18, 2010

NBW, JQP –862.1345Glucose Test System

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.

iPhone

Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for UseMobile

Platform

8 K122260 Sep 12, 2012

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.

Apple IOS Handheld devices

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for Use Mobile Platform

10 K121590 Sep 20, 2012

LXV –UnclassifiedVestibular Analysis Apparatus

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.

Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for Use Mobile Platform

11 K102939

K121470(BlueToothenabled version)

Feb 23, 2011

Jun 14, 2012

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.

iPhone, iPod, iPad

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for UseMobile

Platform

12 K111438 Sep 12, 2011

DPS – 870.2340Electrocardiograph

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.

Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for UseMobile

Platform

13 K121527K120896

Same device submitted by two different companies.

Jun 28, 2012Jul 26, 2012

MNW – 870.2770Impedance Plethysmograph

“Electronic Body Fat Scale”

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.

iPod Touch, iPhone, iPad

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Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for UseMobile

Platform

14 K112921 May 16, 2012

DSI – 870.1025Arrhythmia Detector Alarm

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.

Windows Mobile, Android OS PDA

Appendix

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IDFDA 510(k)

NumberClearance

Date

FDA Classification Product Code

and Classification Reference

Indications for Use Mobile Platform

15 K121758 Oct 9, 2012

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.

iPod Touch, iPhone, iPad