Mobile Medical Applications

Size: px
Start display at page:

Download "Mobile Medical Applications"

Transcription

1 Mobile Medical Applications What Is the Impact of FDA s New MMA Guidance for the Life Science Industry? June 6, 2014, 11:15 AM 12:15 PM Presented by: Mark Gardner, M.B.A., J.D.

2 Agenda 1. How does FDA regulate mobile medical applications (MMAs) in light of FDA s new guidance? 2. Practical implications of new guidance What should companies consider when designing, manufacturing and selling MMAs? 3. Updates on MMAs and FDA 4. Questions at the end; please ask as we go too!

3 Martin Cooper invented the cellular phone at Motorola in the 1970s. Things have obviously changed a lot since then!

4 4 Credit: Hykano

5 Mobile Growth is Exponential 500 million users of health care apps by billion users of health care apps by 2018! Some for professional use others for personal

6 HOW DOES FDA REGULATE MOBILE MEDICAL APPLICATIONS?

7

8 At a Base Not all apps are medical devices just because they have health related functions Calorie counters and fitness apps are NOT MMAs Mobile apps that are medical devices by definition may not be regulated as such due to FDA enforcement policy FDA is focusing on high-risk apps apps that will hurt people if they malfunction

9 A Little History 1989 FDA put out its policy on computer products and software Called the FDA Policy for the Regulation of Computer Products, a.k.a., Draft Software Policy It declared software products were medical devices It was withdrawn in 2005

10 More Recent History 2011 Medical Device Data Systems (MDDS) downclassified from Class III medical devices (high-risk) to Class I (low-risk) on 2/15/ Has led to a great deal of interest in the MDDS space Sept. 25: MMA guidance finalized draft guidance was issued 9/21/2011

11 Definitions (are important) Mobile platform Commercial off-the-shelf (COTS) computing platforms Handheld in nature, e.g., mobile phones, tablets, laptops. Mobile Application (Mobile App), e.g.: My Fitness Pal ihealth WebMD Mobile Medical Application (MMA) Meets definition of a medical device under 201(h) of the FD&C Act; AND either: Accessory to medical device; OR Transforms a mobile platform into a medical device

12 Intended Use is Key in Determining Regulatory Classification Intended use determines if an app is a medical device Medical devices are: intended to treat, cure, prevent, mitigate or diagnose disease; OR intended to affect the structure or any function of the body Device definition at 201(h) of the FD&C Act Intended use (21 CFR 801.4) shown by : Labeling claims Advertising materials Oral / written statements Implied or expressed claims

13 Definitions MMA Manufacturer Includes those that create, design, develop, label, re-label, etc., MMAs Or people that commission the creation of MMAs Includes MMAs that can be accessed over the web Non-MMA manufacturers Makers of apps that have no medical device functions Distributors, e.g., itunes, Android market, are not MMA manufacturers Internet providers, cloud hosting HCPs, making apps for patients Research and teaching medical apps (consider IDE regs.)

14 Scope of FDA Guidance FDA focuses on mobile apps that: (1) meet the statutory definition of a device, under 201(h)*; and (2) are either intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform (e.g., iphone) into a regulated medical device *Recall intended use discussion

15 Practical Reality Many app makers out there have no idea they are actually MMA manufacturers They are making medical devices (MMAs) and do not know it! As a result, many MMAs are misbranded and adulterated These companies face legal and regulatory exposure They are also at a competitive disadvantage

16 Practical Reality Companies that market and manufacture MMAs improperly face FDA enforcement risk Warning Letters Consent Decrees Seizure Publicity Business disruption or effective shut-down can be catastrophic

17 Practical Reality If this is news Get into compliance! Determine regulatory classification MMA? Unregulated mobile app? An app FDA will exercise enforcement discretion regarding? MMAs can be Class I (low risk), II (medium) or III (high) depending on FDA Product Code Among other things, register/list, follow Quality System (QS) requirements, 21 CFR 820 Good Manufacturing Practices (GMPs)

18 Types of Apps that are the Focus of FDA s Regulatory Oversight (1) Apps that are an extension of a medical device via connection (wire or wireless) used to control a device or displaying, storing, analyzing or transmitting patient specific device data Examples: Picture Archiving Communication Systems (PACS) Medical Device Data Systems (MDDS) Apps that control devices, e.g., delivery of insulin via a pump determined by an app blood pressure cuffs being run by apps

19 Example Accessory to a Regulated Medical Device Users can check their blood pressure using a regulated medical device and their iphone or ipad The app controls the cuff via the touchscreen The app also tracks information, e.g., daily read outs

20 Types of Apps that are the Focus of FDA s Regulatory Oversight (2) Apps that transform a mobile platform, e.g., your iphone, into a regulated medical device by using: Attachments Display screens Sensors Or other functions of a phone, e.g., the LED light Some that exist now Others on the horizon!

21 Example Transforming a Mobile Platform into a Regulated Medical Device iphones have an LED light that theoretically could be used by a doctor to examine patients Is my iphone now a medical device? It depends! How is the product marketed? If it is marketed to illuminate general objects, then no, probably not a device If it is marketed as a light source for ophthalmologists to examine patients, e.g., an ophthalmoscope, then the app has transformed my phone into a regulated medical device!

22 More Examples Transforming a Mobile Platform into a Regulated Medical Device Attaching: a blood glucose strip reader to my iphone to function as a glucose meter electrocardiograph (ECG) electrodes to my tablet to measure, store and display ECG signals Using built-in components: phone accelerometer for sleep apnea monitoring sensors for creating an electronic stethoscope Displaying radiographic images for diagnosis

23 Types of Apps that are the Focus of FDA s Regulatory Oversight (3) Apps that become regulated medical devices by performing patient-specific diagnosis or treatment recommendations Apps that calculate dosage plans Apps that give treatment recommendations If you want to avoid being regulated under this classification, consider whether you need to provide patient-specific advice

24 What does FDA enforcement discretion actually mean?

25 Apps for which FDA Intends to Exercise Enforcement Discretion Apps that: (1) help patients self-manage their disease without providing specific treatment or suggestions (general coaching for patients); e.g.: Skill of the Day apps for patients with mental challenges (2) provide patients with simple tools to help them track and organize health data e.g., blood pressure tracking tool (3) provide easy access to information related to patients health conditions or treatments e.g., drug allergy look-up tools

26 Apps for which FDA Intends to Exercise Enforcement Discretion Apps that: (4) help patients document, show, or communicate medical conditions to providers; e.g. a camera used for documenting a wound (5) automate simple tasks for providers; OR e.g., BMI calculation (6) enable patients or providers to interact with records. e.g., Personal Health Record (PHR) or Electronic Health Record (EHR) systems

27 Apps that are NOT MMAs Apps that are generic aids or general purpose products, For example: Using an Android phone as a magnifying glass Such apps cannot be not intended for medical purposes not regulated under 21 CFR , Magnifying Spectacles Record audio, amplify audio

28 Apps that are NOT MMAs Apps that: Provide education/training tools not intended to treat, diagnose or be used clinically Maps to special gluten free restaurants Automate general business functions in an office, e.g., apps that: Determine billing codes and facilitate insurance claims Generate appointment reminders Provide wait times in facilities Help patients pay their medical bills

29 Summary of Apps and FDA Regulatory Oversight Mobile apps that FDA regulates Enforcement discretion mobile apps Mobile apps that FDA does NOT regulate Risk to patients? Low, Medium or High Low Low/none Considered a mobile medical application, i.e., a medical device? FDA Clearance or Approval Required? Additional Regulatory Requirements? Yes Maybe No Perhaps, depending on FDA product code Yes QS, register/list, MDR P&Ps, etc. No No, but encouraged to by FDA No No Example of functions? Intended to diagnose, treat, cure, prevent or mitigate disease? -Controls a regulated medical device -Transforms a mobile platform into a device -Data management -Coaching -Reminders -Documentation -Simple calculations Maybe Maybe No -Audio recording, amplification -Education -Business operations

30 Additional Regulatory Requirements for Class I MMA Makers MMR makers of Class I* devices must follow general controls : Register annually and list devices with FDA (21 CFR 807); Registration fees, 2014: $3313 and 2015: $3750 Comply with the Quality System (QS) regulation (21 CFR 820) Following labeling requirements (21 CFR 801); Medical Device Reporting (21 CFR 803); Must report device failures which caused or contributed to death or serious injury or will in the future *Class is dependent on product code Know your code

31 Additional Regulatory Requirements for Class I MMA Makers (continued) MMR makers of Class I devices must follow general controls : Provide premarket notification if necessary (21 CFR 807); Report corrections and removals (21 CFR 806); and Follow the Investigational Device Exemption (IDE) regulations (21 CFR 812)

32 Additional Regulatory Requirements for Class II & III MMA Makers Class II and III MMA makers must follow all general controls for Class I devices which we just covered Plus: Special controls for most Class II devices Premarket Approval (21 CFR 814) for Class III devices

33 PRACTICAL IMPLICATIONS OF NEW GUIDANCE

34 MMA Company Question Checklist Classification Is the app the type that FDA cares about? Or will FDA use enforcement discretion? Can the app be safely used by a patient without active oversight by a medical professional? If something goes wrong with the app, is it going to hurt someone? Documentation supporting: i) the assigned app product code, ii) why the app is not regulated, or iii) reasons why it fits under the enforcement discretion bucket?

35 MMA Company Question Checklist More on Product Codes If my device is acting as an accessory to a regulated device, or is transforming a mobile platform into a regulated medical device then what Product Code does it fall under? Are the appropriate regulations being followed?

36 MMA Company Question Checklist Claims What is the intended use of the app? If it is an MMA, do the claims match my product code? If it is a Class I app, are claims made which go beyond the CFR it is regulated under? Off-label claims?

37 MMA Company Question Checklist Other regulatory requirements met? Quality System established? ISO 9001, ISO 13485, Special Controls? Policies and procedures in place? Registered and products listed? MDR reporting and documentation in place? Following FDA s recommendation to follow Quality System requirements for enforcement discretion apps? Necessary or not?

38 NEWS

39 Latest Intel on MMAs MMA FDA clearance/approval process is lagging The Agency recently defended its tardiness Bakul Patel told the audience that in 80 percent of the cases the agency has met the statutory 90-day timeframe under the 510(k) process Health Data Management Feb. 25, 2014 Some calling for a new legal definition and therefore regulatory class of products, i.e., medical software

40 Latest Intel on MMAs Many new MMAs have been cleared ~100 have been cleared and approved since 1997 Picking up See examples of MMAs FDA Has Cleared or Approved at: ocedures/connectedhealth/mobilemedicalapplications/uc m htm. Many app makers are participating illegally in the market place Investors continue to invest in this new space area of great growth in Silicon Valley

41 The end. Questions? Contact info: Mark Gardner, M.B.A., J.D. (612) Copyright 2014 DuVal & Associates, P.A. All rights reserved.

FDA Issues Final Guidance on Mobile Medical Apps

FDA Issues Final Guidance on Mobile Medical Apps ADVISORY September 2013 FDA Issues Final Guidance on Mobile Medical Apps On September 23, 2013, the U.S. Food & Drug Administration (FDA or the Agency) issued its final Guidance for Industry and Food and

More information

CENTER FOR CONNECTED HEALTH POLICY

CENTER FOR CONNECTED HEALTH POLICY CENTER FOR CONNECTED HEALTH POLICY The Center for Connected Health Policy (CCHP) is a public interest nonprofit organization that develops and advances telehealth policy solutions to promote improvements

More information

Medical Device Software: Establishing FDA Authority and Mobile Medical Apps

Medical Device Software: Establishing FDA Authority and Mobile Medical Apps Medical Device Software: Establishing FDA Authority and Mobile Medical Apps Seth A. Mailhot, Partner Lead, FDA Regulatory Practice Overview Applying the Definition of a Device to Software Special Categories

More information

Regulation of Mobile Medical Apps

Regulation of Mobile Medical Apps Regulation of Mobile Medical Apps May 30, 2014 Copyright 2014 Software Quality Consulting Inc. Slide 1 Speaker Bio Steven R. Rakitin has over 35 years experience as a software engineer and 25 years in

More information

Mobile Medical Applications: An Overview of FDA Regulation

Mobile Medical Applications: An Overview of FDA Regulation Mobile Medical Applications: An Overview of FDA Regulation RAPS Annual Convention 2014 Austin, Texas Michael A. Swit, Esq. Special Counsel, FDA Law Practice Duane Morris LLP Standard Disclaimers The views

More information

The U.S. FDA s Regulation and Oversight of Mobile Medical Applications

The U.S. FDA s Regulation and Oversight of Mobile Medical Applications The U.S. FDA s Regulation and Oversight of Mobile Medical Applications The U.S. FDA s Regulation and Oversight of Mobile Medical Applications As smart phones and portable tablet computers become the preferred

More information

Mobile Medical Application Development: FDA Regulation

Mobile Medical Application Development: FDA Regulation Mobile Medical Application Development: FDA Regulation Mobile Medical Applications: Current Environment Currently over 100,000 mobile health related applications are available for download; there is an

More information

The Shifting Sands of Medical Software Regulation

The Shifting Sands of Medical Software Regulation The Shifting Sands of Medical Software Regulation Suzanne O Shea Ralph Hall September 10, 2014 What Software is Regulated by FDA? FDA regulates medical devices. FDA regulates software that meets the definition

More information

FDA Regulation of Health IT

FDA Regulation of Health IT FDA Regulation of Health IT September 2014 Marian J. Lee Partner +1 (202) 661 7955 mlee@kslaw.com Agenda FDA s Mobile Medical Applications Guidance FDA Draft Guidance on Medical Device Data Systems (MDDS),

More information

FDA Regulation of Health IT

FDA Regulation of Health IT FDA Regulation of Health IT May 2014 Marian J. Lee Partner King & Spalding +1 (202) 661 7955 mlee@kslaw.com Agenda FDA s Mobile Medical Applications Guidance FDASIA Health IT Report 2 FDA s Mobile Medical

More information

Use of Mobile Medical Applications in Clinical Research

Use of Mobile Medical Applications in Clinical Research Use of Mobile Medical Applications in Clinical Research Erin K. O Reilly, PhD RAC Associate Director, Regulatory Affairs Duke Translational Medicine Institute erin.oreilly@duke.edu September 10, 2014 (919)

More information

Mobile Medical Applications. Guidance for Industry and Food and Drug Administration Staff

Mobile Medical Applications. Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff Document issued on: September 25, 2013 The draft of this guidance was issued on July 21, 2011. For questions regarding

More information

Loss Control Webinar Series. Mobile Medical Apps: FDA Regulation and Products Liability Implications 10-23-2013

Loss Control Webinar Series. Mobile Medical Apps: FDA Regulation and Products Liability Implications 10-23-2013 Loss Control Webinar Series Mobile Medical Apps: FDA Regulation and Products Liability Implications 10-23-2013 www.goldbergsegalla.com NEW YORK PENNSYLVANIA CONNECTICUT NEW JERSEY UNITED KINGDOM Mobile

More information

Risk based 12/1/2015. Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director.

Risk based 12/1/2015. Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director. Digital Health Bakul Patel Associate Director for Digital Health Office of Center Director Center for Devices and Radiological Health 1 Oversight Approach Platform independent Promote innovation Promote

More information

Mobile Medical Apps. Purpose. Diane Romza Kutz Fredric E. Roth V. Regulation and Risks. Purpose of today s presentation

Mobile Medical Apps. Purpose. Diane Romza Kutz Fredric E. Roth V. Regulation and Risks. Purpose of today s presentation Mobile Medical Apps Regulation and Risks Diane Romza Kutz Fredric E. Roth V Purpose Purpose of today s presentation Identify the newly-regulated industry Identify the newly regulated products and the basis

More information

Templates. FDA Mobile Medical App Regulations. Your own sub headline This is an example text. Your Logo

Templates. FDA Mobile Medical App Regulations. Your own sub headline This is an example text. Your Logo Templates FDA Mobile Medical App Regulations Your own sub headline This is an example text Your Logo FDA Oversight of Medical Devices The latest Guidance from the FDA Tom Richards MD/MS trichards0445@me.com

More information

Draft Guidance for Industry and Food and Drug Administration Staff

Draft Guidance for Industry and Food and Drug Administration Staff Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on:

More information

Mobile Medical Applications: FDA s Final Guidance. M. Elizabeth Bierman Anthony T. Pavel Morgan, Lewis & Bockius, LLP

Mobile Medical Applications: FDA s Final Guidance. M. Elizabeth Bierman Anthony T. Pavel Morgan, Lewis & Bockius, LLP Mobile Medical Applications: FDA s Final Guidance Michele L. Buenafe M. Elizabeth Bierman Anthony T. Pavel Morgan, Lewis & Bockius, LLP 1 Background FDA has a long-standing policy to regulate any computer

More information

Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA

Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA Developing a Mobile Medical App? How to determine if it is a medical device and get it cleared by the US FDA In this presentation: App stats: Explosive growth Examples already cleared by the US FDA Is

More information

Medical Device Software

Medical Device Software Medical Device Software Bakul Patel Senior Policy Advisor 1 Overview Medical devices and software Oversight principles and Current approach Trends, Challenges and opportunities Addressing challenges 2

More information

ALERT. FDA Guidance for Industry and FDA Staff: Mobile Medical Applications. Health & FDA Business November 2013

ALERT. FDA Guidance for Industry and FDA Staff: Mobile Medical Applications. Health & FDA Business November 2013 ALERT Health & FDA Business November 2013 FDA Guidance for Industry and FDA Staff: Mobile Medical Applications On September 25, 2013, the Food and Drug Administration (the FDA ) released final guidance

More information

Regulatory Landscape For Mobile Medical Apps (MMAs)

Regulatory Landscape For Mobile Medical Apps (MMAs) Regulatory Landscape For Mobile Medical Apps (MMAs) Date: December 6, 2013 Place: Erie County Bar Association, MidDay Learning Program Where value is law. Monika Bhatt mbhatt@hodgsonruss.com Blog: GatewayFDA.com

More information

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document

More information

Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications

Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications 2015 Annual Conference Washington, DC Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center

More information

Thomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015

Thomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015 Thomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015 All slides and accompanying comments, ideas, arguments and other statements of any kind are personal to

More information

The iphone as a Medical Device

The iphone as a Medical Device The iphone as a Medical Device Presented by: Melissa L. Markey, Esq. Hall, Render, Killian, Heath & Lyman, PLLC 201 West Big Beaver Rd, Suite 315 Troy, Michigan (248) 740-7505 Hall, Render, Killian, Heath

More information

Cutting Edge Issues in Health Care Technology & mhealth. Agenda

Cutting Edge Issues in Health Care Technology & mhealth. Agenda Cutting Edge Issues in Health Care Technology & mhealth Vernessa Pollard July 2014 Agenda The Regulatory Landscape Jurisdiction and Authority Over Mobile Health Products Requirements, Compliance and Enforcement

More information

On Behalf of: InTouch Health

On Behalf of: InTouch Health On Behalf of: InTouch Health White Paper FDA Regulation of Mobile Health Technologies The Current Regulatory Framework as Applied to InTouch Health s Telemedicine Solution June 15, 2012 TABLE OF CONTENTS

More information

Regulating the Initial Wave of Mobile Medical Apps

Regulating the Initial Wave of Mobile Medical Apps Regulating the Initial Wave of Mobile Medical Apps AACC Emerging Technologies Conference Scott L. Cunningham Agenda Basics of FDA Device Regulation Mobile Medical Apps 2 Basics of FDA Medical Device Regulation

More information

Regulatory Considerations for Medical Device Software. Medical Device Software

Regulatory Considerations for Medical Device Software. Medical Device Software Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan

More information

Which Apps Does FDA Regulate?

Which Apps Does FDA Regulate? Which Apps Does FDA Regulate? Bradley Merrill Thompson 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 1 Topics for Discussion Which apps does FDA regulate? Enforcement Discretion Pharma Apps Future

More information

Overview of FDA Compliance for Medical Devices

Overview of FDA Compliance for Medical Devices Glisland Training Series: Overview of FDA Compliance for Medical Devices Glisland, Inc. San Jose, California, USA http://www.glisland.com Description This course provides a concise overview of how FDA

More information

Rethinking the FDA s Regulation of. By Scott D. Danzis and Christopher Pruitt

Rethinking the FDA s Regulation of. By Scott D. Danzis and Christopher Pruitt Rethinking the FDA s Regulation of Mobile Medical Apps By Scott D. Danzis and Christopher Pruitt Smartphones and mobile devices have rapidly become part of everyday life in the United States. It is no

More information

MOBILE MEDICAL APPLICATIONS

MOBILE MEDICAL APPLICATIONS October 7, 2013 EVOKE HEALTH POINT OF VIEW MOBILE MEDICAL APPLICATIONS FDA GUIDANCE FOR INDUSTRY FOR MORE INFORMATION: Mark McConaghy, VP, Strategy Evoke Health 267.765.4998 mark.mcconaghy@evokehealth.com

More information

Medical Device Communiqué

Medical Device Communiqué What Does the Med Tech Industry Face Globally? 1 Changes at FDA and CDRH 3 Mobile Medical App Guidance from FDA 4 UL and the UL logo are trademarks of UL LLC 2013. What Does the Med Tech Industry Face

More information

FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts

FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts Clinical Laboratory Improvement Advisory Committee Meeting Centers for Disease Control and Prevention February 15, 2012 Tremel A. Faison,

More information

On Behalf of: InTouch Health

On Behalf of: InTouch Health On Behalf of: InTouch Health White Paper FDA Regulation of Mobile Health Technologies The Current Regulatory Framework as Applied to InTouch Health s Telehealth Solutions June 15, 2012; Updated June 15,

More information

US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR

US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR US & CANADA: REGULATION AND GUIDELINES ON MEDICAL SOFTWARE AND APPS OR A MEDICAL DEVICE IS A MEDICAL DEVICE IS A MEDICAL DEVICE AHWP Medical SW Workshop Taipei, Taiwan November 3, 2012 John G. Abbott,

More information

EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software DECISION SUMMARY

EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software DECISION SUMMARY A. DEN Number: DEN140016 EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR STUDIO on the Cloud Data Management Software B. Purpose for Submission: DECISION SUMMARY De novo request for adjunct data management

More information

Robert Jarrin Senior Director, Government Affairs. May 22, 2013

Robert Jarrin Senior Director, Government Affairs. May 22, 2013 Robert Jarrin Senior Director, Government Affairs May 22, 2013 1 Section 201(h) FD&C Act "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related

More information

International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update

International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update International Medical Device Regulators Forum (IMDRF) US FDA Center for Devices and Radiological Health - Update Kimberly A. Trautman Associate Director, International Affairs Office of the Center Director

More information

CDRH Regulated Software

CDRH Regulated Software CDRH Regulated Software An Introduction John F. Murray Jr. CDRH Software Compliance Expert CDRH Regulates Software in the following areas Medical Devices Automation of Production Systems Automation of

More information

CDRH Regulated Software Looking back, looking forward

CDRH Regulated Software Looking back, looking forward CDRH Regulated Software Looking back, looking forward Medical Device Software Compliance Expert US Food & Drug Administration at the Regulatory Affairs Professional Society Indianapolis, Indiana Goal of

More information

Regulation of Medical Apps FDA and European Union

Regulation of Medical Apps FDA and European Union JHW Comment - The content of below article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Erik Vollebregt Erik is a

More information

Understanding Medical Device Regulation for mhealth A Guide for Mobile Operators

Understanding Medical Device Regulation for mhealth A Guide for Mobile Operators for mhealth A Guide for Mobile Operators 1 Foreword Mobile technologies will make a significant contribution to addressing the enormous challenges of healthcare provision worldwide. Early efforts in mobile

More information

REFERENCE DOCUMENT. (DRAFT for Public Comments) Title: White Paper on Medical Device Software Regulation Software Qualification and Classification

REFERENCE DOCUMENT. (DRAFT for Public Comments) Title: White Paper on Medical Device Software Regulation Software Qualification and Classification AHWP/WG1/R001:2014 REFERENCE DOCUMENT (DRAFT for Public Comments) Title: White Paper on Medical Device Software Regulation Software Qualification and Classification Author: Work Group 1, Pre-Market Submission

More information

The Human Experiment- Electronic Medical/Health Records

The Human Experiment- Electronic Medical/Health Records The Human Experiment- Electronic Medical/Health Records Patient safety is one of the primary stated intentions behind the push for computerized medical records. To the extent illegible handwriting leads

More information

Activating Standardization Bodies Around Medical Apps

Activating Standardization Bodies Around Medical Apps Activating Standardization Bodies Around Medical Apps Michael J. Ackerman, Ph.D. Assistant Director High Performance Computing and Communications U.S. National Library of Medicine The views and opinions

More information

August 18, 2015. Re: Section 1201 Rulemaking Proposed Exemption for Medical Devices

August 18, 2015. Re: Section 1201 Rulemaking Proposed Exemption for Medical Devices DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 August 18, 2015 Ms. Jacqueline C. Charlesworth General Counsel

More information

Mobile Medical Applications (MMAs)

Mobile Medical Applications (MMAs) Mobile Medical Applications (MMAs) Prithul Bom, MBA, RAC, CSQE Senior Director, Medical Device & Diagnostics Development Chiltern Elizabeth Brooks, PhD President, Decision Driver Analytics Introduction

More information

The Legal Aspects of Regulatory Compliance

The Legal Aspects of Regulatory Compliance The Legal Aspects of Regulatory Compliance Terry G. Mahn Fish & Richardson P.C. 14-Dec-04 202-783-5070 www.fr.com I. General Theories of Legal Liability Administrative Law FCC * EMC, radio standards, equipment

More information

RUTGERS LAW RECORD The Internet Journal of Rutgers School of Law Newark www.lawrecord.com

RUTGERS LAW RECORD The Internet Journal of Rutgers School of Law Newark www.lawrecord.com RUTGERS LAW RECORD The Internet Journal of Rutgers School of Law Newark www.lawrecord.com Volume 42 2014-2015 MOBILE MEDICAL APPS: THE NEW MEDICAL DEVICES? ARUNDHATI MOHANKUMAR 1 Overview And Intro Imagine

More information

Where s the App for That?

Where s the App for That? Where s the App for That? Mobile Medical Apps, Cybersecurity and the Regulatory and Litigation Landscape Sharon R. Klein Jan P. Levine Angelo A. Stio, III PBI Health Law Institute 2016 Spring 2016 1 Today

More information

General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff

General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff General Wellness: Policy for Low Risk Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document

More information

KIZ 2,33-3 p8 ~ 510(k) Summary. As required by 21 CFR 807.92(c) 510(k) Premarket Notification Submission AFrame Digital MobileCare Monitor.

KIZ 2,33-3 p8 ~ 510(k) Summary. As required by 21 CFR 807.92(c) 510(k) Premarket Notification Submission AFrame Digital MobileCare Monitor. KIZ 2,33-3 p8 ~ 510(k) Premarket Notification Submission AFrame Digital MobileCare Monitor 510(k) Summary f 1 As required by 21 CFR 807.92(c) Submitter: 510(k) Owner: AFrame Digital, Inc. Address:.1889

More information

I N S I D E T H E M I N D S

I N S I D E T H E M I N D S I N S I D E T H E M I N D S Recent Developments in Food and Drug Law Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-To-Date with FDA Requirements, and Developing Compliance Practices

More information

Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca

Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca Software Regulated as a Medical Device Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca Therapeutic Products Directorate Director General S. Sharma

More information

Webinar: Implications of FDA Regulation of Medical Devices: When is an ipad More Than an ipad?

Webinar: Implications of FDA Regulation of Medical Devices: When is an ipad More Than an ipad? Webinar: Implications of FDA Regulation of Medical Devices: When is an ipad More Than an ipad? Additional resources on this topic may be found at: www.aamc.org/fdamobiledevice Sharon Klein, Esq. Pepper

More information

Inspections, Compliance, Enforcement, and Criminal Investigations

Inspections, Compliance, Enforcement, and Criminal Investigations Page 1 of 7 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2014 Inspections, Compliance, Enforcement, and Criminal Investigations

More information

Tracking The Likelihood Of Liability From Health Apps --By Kevin M. Henley, Arnold & Porter LLP

Tracking The Likelihood Of Liability From Health Apps --By Kevin M. Henley, Arnold & Porter LLP Published by Product Liability Law360 on March 11, 2015. Also ran in Health Law360, Life Sciences Law360, and Technology Law360. Tracking The Likelihood Of Liability From Health Apps --By Kevin M. Henley,

More information

Mobile Medical Apps. 34% of Adults 34% App = Application; = a self contained program or piece of software designed to fulfill a particular purpose;

Mobile Medical Apps. 34% of Adults 34% App = Application; = a self contained program or piece of software designed to fulfill a particular purpose; Mobile Medical Apps CONSTANTINE GEAN, MD, MS, MBA, FACOEM AOHC 2014 April 30, 2014 DISCLAIMERS ( Aka, My lawyer told me to say nothing I say matters and it s not my fault :) THESE APPS ARE PRESENTED FOR

More information

The Regulation of Medical Device Apps

The Regulation of Medical Device Apps The Regulation of Medical Device Apps Prepared for West of England Academic Health Science Network and University of Bristol June 2014 June 2014 1 Table of Contents 1 Purpose...3 2 Scope...3 3 The Regulation

More information

Building 6, Suite 300 RyeBrook, NY 10573 C-ontact-N~ame: --- William H-. Schofield Director of TeleHealth Operations. Signal,_Radiofrequency

Building 6, Suite 300 RyeBrook, NY 10573 C-ontact-N~ame: --- William H-. Schofield Director of TeleHealth Operations. Signal,_Radiofrequency Optimealth Care Solutions, Inc. Traditional.51/0(k) Opion Telel-ealib Application 510(k) Summary: K130971 Manufacturer Name: Optum Health Care Solutions, Inc. Address:T1oo King Street Building 6, Suite

More information

Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Development and FDA Regulations IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa Medical Product Development and FDA Regulations Introduction Regulated FDA Overview Medical

More information

510(k) Summary May 7, 2012

510(k) Summary May 7, 2012 510(k) Summary Medicalgorithmics 510(k) Premarket Notification 510(k) Summary May 7, 2012 1. Submitter Name and Address Medicalgorithmics LLC 245 West 107th St., Suite 11A New York, NY 10025, USA Contact

More information

A LEGAL AND PRACTICAL GUIDE TO DEVELOPING

A LEGAL AND PRACTICAL GUIDE TO DEVELOPING A LEGAL AND PRACTICAL GUIDE TO DEVELOPING MOBILE MEDICAL APPLICATIONS ( APPS ): NAVIGATING A POTENTIAL MINEFIELD Megan Emma Smith 1 19 Meynell Gardens, E9 7AT 07525 432915, London Corresponding Author:

More information

Leveraging Partners and Open Source Technology in your Mobility Strategy. emids webinar Thursday, August 11, 2011 1:00 pm 2:00 pm EDT

Leveraging Partners and Open Source Technology in your Mobility Strategy. emids webinar Thursday, August 11, 2011 1:00 pm 2:00 pm EDT Leveraging Partners and Open Source Technology in your Mobility Strategy emids webinar Thursday, August 11, 2011 1:00 pm 2:00 pm EDT Presenters Jerry Buchanan Account Director emids Technologies Ambarish

More information

FDA & FTC Regulation of Mobile Medical Apps. Michael D. Holloway Institute for Science, Law & Technology IIT Chicago-Kent College of Law April 4, 2014

FDA & FTC Regulation of Mobile Medical Apps. Michael D. Holloway Institute for Science, Law & Technology IIT Chicago-Kent College of Law April 4, 2014 FDA & FTC Regulation of Mobile Medical Apps Michael D. Holloway Institute for Science, Law & Technology IIT Chicago-Kent College of Law April 4, 2014 Smartphones and other mobile devices are playing an

More information

ORACLE CONSULTING GROUP

ORACLE CONSULTING GROUP ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739

More information

Social Media and Apps. Joel E. Tragesser Leslie M. Tector Indiana Medical Device Manufacturers Council Annual Conference October 29, 2015

Social Media and Apps. Joel E. Tragesser Leslie M. Tector Indiana Medical Device Manufacturers Council Annual Conference October 29, 2015 Use and Protection ti of IP in Social Media and Apps Joel E. Tragesser Leslie M. Tector Indiana Medical Device Manufacturers Council Annual Conference October 29, 2015 Social Media Promotes COMMUNICATION

More information

Marketed Unapproved Drugs: FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice

Marketed Unapproved Drugs: FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice Marketed Unapproved Drugs: FDA to Take Immediate Enforcement Action at Any Time, Without Prior Notice Kurt R. Karst Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, D.C.

More information

Tidepool FDA Pre-submission Draft Meeting Minutes

Tidepool FDA Pre-submission Draft Meeting Minutes Tidepool FDA Pre-submission Draft Meeting Minutes October 14, 2014, 2:00pm EDT Food and Drug Administration, 10903 New Hampshire Ave., WO 66, Silver Spring, MD 20993 Pre submission Document ID: Pre submission

More information

MEDICAL APPS AND DEVICES THE CONVERGENCE OF FDA, FTC, AND STATE AND FEDERAL REGULATION

MEDICAL APPS AND DEVICES THE CONVERGENCE OF FDA, FTC, AND STATE AND FEDERAL REGULATION MEDICAL APPS AND DEVICES THE CONVERGENCE OF FDA, FTC, AND STATE AND FEDERAL REGULATION Todd L. Mayover, Senior Corporate Counsel, Thermo Fisher Scientific Barry H. Boise, Partner, Pepper Hamilton LLP Sharon

More information

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE

WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE WHITEPAPER: SOFTWARE APPS AS MEDICAL DEVICES THE REGULATORY LANDSCAPE White paper produced by Maetrics For more information, please contact global sales +1 610 458 9312 +1 877 623 8742 globalsales@maetrics.com

More information

Considerations for using the Web for Medical Device Applications

Considerations for using the Web for Medical Device Applications Considerations for using the Web for Medical Device Applications MEDS, San Diego August 23 rd, 2012 Daniel Sterling, President Who is Sterling? Your Partner in Medical Device Development What we do: o

More information

Regulation and Risk Management of Combination Products

Regulation and Risk Management of Combination Products Regulation and Risk Management of Combination Products Katherine Ulman Associate Scientist Global Regulatory Compliance Manager Dow Corning Healthcare Jim Curtis Senior Specialist, Healthcare Applications

More information

User Agreement. Quality. Value. Efficiency.

User Agreement. Quality. Value. Efficiency. User Agreement Quality. Value. Efficiency. Welcome to QVuE, the Leaders Network on Quality, Value and Efficiency website sponsored by The Medicines Company. The information provided in this Webinar Series

More information

Health Care 2.0: How Technology is Transforming Health Care

Health Care 2.0: How Technology is Transforming Health Care Health Care 2.0: How Technology is Transforming Health Care Matthew Kaiser, CEBS, SPHR Director, HR Technology and Outsourcing Lockton Kansas City, Missouri The opinions expressed in this presentation

More information

Mobile Devices Accelerate Patient Centric Healthcare

Mobile Devices Accelerate Patient Centric Healthcare Mobile Devices Accelerate Patient Centric Healthcare Steven F. Owens 1, MedNest, LLC As this web enabled digital age evolves from desktop computers with modems to mobile computing devices and sensors capable

More information

Guidance for Industry Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator,

Guidance for Industry Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, Reprinted from FDA s website by Guidance for Industry Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, Guidance And Antiasthmatic for Drug Industry Products for Over-the-Counter Labeling

More information

Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories

Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories 14 1 2 3 4 5 6 7 8 9 10 11 12 13 15 16 17 18 19 20 21 22 23 24 25 26 27 Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories Framework for Regulatory Oversight of

More information

Regulated Mobile Applications

Regulated Mobile Applications Regulated Mobile Applications Sion Wyn Conformity +[44] (0) 1492 642622 sion.wyn@conform-it.com Waters, Wilmslow, November 2014 1 Introduction According to industry estimates, 500 million smartphone users

More information

AgaMatrucx. NV2 21 Salem, NH 030794oz 2 1. 510(k) Sumnmary

AgaMatrucx. NV2 21 Salem, NH 030794oz 2 1. 510(k) Sumnmary AgaMatrucx Aga~arix, nc. -7C Ramond venu -, 007S 510(k) Sumnmary This summary of 5 10k) substantial equivalence is being submitted in accordance with the requirements of 21 CER 807.92. Prepared: 05 September

More information

MOBILE TECHNOLOGY IN PATIENT CARE

MOBILE TECHNOLOGY IN PATIENT CARE MOBILE TECHNOLOGY IN PATIENT CARE Elizabeth Urteaga, Pharm.D. National Wellness Conference June 23, 2014 Learning Objectives Identify mobile instruments available to monitor a patient s disease states

More information

Datrix, Inc NOV - 1 2005. Appendix G. 510(k) Summary of Safety and Effectiveness for Datrix, Inc CardioServer ECG Management System

Datrix, Inc NOV - 1 2005. Appendix G. 510(k) Summary of Safety and Effectiveness for Datrix, Inc CardioServer ECG Management System Appendix G NOV - 1 2005 510(k) Summary of Safety and Effectiveness for CardioServer ECG Management System 1. DATE SUMMARY PREPARED: 9-26-2005 2. SUBMITTER'S NAME AND ADDRESS: Linda Gluckman 340 State Place

More information

FDA Pre-Submission Cover Letter

FDA Pre-Submission Cover Letter 3 physical copies and 1 ecopy to: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center WO66 G609 10903 New Hampshire Avenue Silver Spring, MD 20993 0002

More information

Guidance for Industry. Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products

Guidance for Industry. Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products Guidance for Industry Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products Small Entity Compliance Guide Written comments and suggestions may be

More information

FDA Regulation of Hearing Aids. Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic and ENT Devices ODE/CDRH/FDA

FDA Regulation of Hearing Aids. Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic and ENT Devices ODE/CDRH/FDA FDA Regulation of Hearing Aids Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic ENT ODE/CDRH/FDA U.S. Food Drug Administration Presentation Outline Overview of device regulations riskbased

More information

Turning Patient Portals into Major EHR Assets Edward Fotsch, M.D. Douglas Gentile, M.D.

Turning Patient Portals into Major EHR Assets Edward Fotsch, M.D. Douglas Gentile, M.D. Turning Patient Portals into Major EHR Assets Edward Fotsch, M.D. Douglas Gentile, M.D. DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily

More information

Introduction to Compliance with FDA Labeling and Advertising Requirements

Introduction to Compliance with FDA Labeling and Advertising Requirements Introduction to Compliance with FDA Labeling and Advertising Requirements Second Annual Pharmaceutical Industry Regulatory and Compliance Summit Dick Kenny FDA History Basic function of government Oldest

More information

[DOCKET NO.96N-0002] DRAFT

[DOCKET NO.96N-0002] DRAFT [DOCKET NO.96N-0002] DRAFT DRAFT DOCUMENT CONCERNING THE REGULATION OF PLACENTAL/UMBILICAL CORD BLOOD STEM CELL PRODUCTS INTENDED FOR TRANSPLANTATION OR FURTHER MANUFACTURE INTO INJECTABLE PRODUCTS DECEMBER,

More information

Lessons Learned from Expanding the Boundaries of the EMR

Lessons Learned from Expanding the Boundaries of the EMR Lessons Learned from Expanding the Boundaries of the EMR Phyllis Teater and Thomas Bentley DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily

More information

A Guide for Patients of Abington Park Surgery

A Guide for Patients of Abington Park Surgery A Guide for Patients of Abington Park Surgery This guide covers the following topics: About SystmOnline Logging in to SystmOnline Changing/Resetting Your Password Logging Out of SystmOnline Managing Appointments

More information

EU and US regulation of health information technology, software and mobile apps

EU and US regulation of health information technology, software and mobile apps EU and US regulation of health information technology, software and mobile apps www.practicallaw.com/3-518-3154 Lincoln Tsang, Vernessa Pollard and Daniel Kracov Arnold & Porter LLP The emergence of integrated

More information

Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations. Proposed Final IMDRF WG(PF)/N12 R10

Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations. Proposed Final IMDRF WG(PF)/N12 R10 Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations Proposed Final IMDRF WG(PF)/N12 R10 Bakul Patel, IMDRF WG Chair Goals International convergence

More information

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0798] Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices;

More information

Interplay Between FDA Advertising and Promotion Enforcement Activities, Product Liability, and Consumer Fraud Litigation

Interplay Between FDA Advertising and Promotion Enforcement Activities, Product Liability, and Consumer Fraud Litigation Interplay Between FDA Advertising and Promotion Enforcement Activities, Product Liability, and Consumer Fraud Litigation Leslie M. Tector Quarles & Brady LLP September 30, 2014 Objectives Which federal

More information

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Frequently Asked Questions About Medical Devices Additional copies are available from: Office of Good Clinical Practice Office

More information

FDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle

FDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle FDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle Kurt R. Karst Associate Hyman, Phelps & McNamara, P.C. 700 Thirteenth

More information

Medical Apps and Devices

Medical Apps and Devices Medical Apps and Devices The Convergence of FDA, FTC, and State and Federal Regulation Barry H. Boise T. Stephen Jenkins Moderated by Mark A. Kadzielski Health Care Services Webinar December 17, 2015 1

More information