Covidien - FDA Guidance on Mobile Medical Apps 140124
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Covidien - FDA Guidance on Mobile Medical Apps 140124

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Presentation given on 1/24/14 to Covidien legal team offsite meeting.

Presentation given on 1/24/14 to Covidien legal team offsite meeting.

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    Covidien - FDA Guidance on Mobile Medical Apps 140124 Covidien - FDA Guidance on Mobile Medical Apps 140124 Presentation Transcript

    • Final FDA Guidance for Mobile Medical App Developers and Food and Drug Administration Staff January 24, 2014 Jason D. Haislmaier jason.haislmaier@bryancave.com Copyright 2013 BryanCave LLP Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave Copyright 2014 Jason D. Haislmaier
    • This presentation is intended for general informational purposes only and should not be construed as legal advice or legal opinion on any specific facts or circumstances, nor is it intended to address specific legal compliance issues that may arise in particular circumstances. Please consult counsel concerning your own situation and any specific legal questions you may have. The thoughts and opinions expressed in this presentation are those of the individual presenters and do not necessarily reflect the official or unofficial thoughts or opinions of their employers. For further information regarding this presentation, please contact the presenter(s) listed in the presentation. Unless otherwise noted, all original content in this presentation is licensed under the Creative Commons Creative Commons Attribution-Share Alike 3.0 United States License available at: http://creativecommons.org/licenses/by-sa/3.0/us. Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Apps Mobile Apps Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • The FDA U.S. Food and Drug Administration (FDA) www.fda.gov Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • FDA Authority Federal Food, Drug, and Cosmetic (FD&C) Act • 21 USC Chapter 9 • Passed by Congress in 1938 • Provides authority to the FDA to oversee the safety of food, drugs, and cosmetics • Also provides FDA with authority over “medical devices” Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical Applications History of FDA Scrutiny • FDA has long recognized that the “unique characteristics” of mobile platforms may “pose additional or different risks” • FDA has noted the increasing proliferation of mobile medical apps – Currently 97,000 mobile health apps in Apple's App Store that have generated 3 million free and 300,000 paid downloads – 500 million smartphone users worldwide will be using health care apps by 2015 – 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health apps by 2018 – While a significant number (43%) of apps are primarily designed for healthcare professionals, users will increasingly include consumers and patients • Guidance by the FDA is not at all surprising Source: Global Mobile Health Market Report 2010-2015, research2guidance, http://www.research2guidance.com/500m-people-will-be-using-healthcare-mobile-applications-in-2015/ Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical Applications Many Drivers for FDA Concern • Increasing sophistication of mobile medical apps – Capable of transforming mobile platforms into medical devices – Appearing as “accessories” to regulated medical devices – Apps running through a network connected mobile platform (the “cloud”) • Increasing demand for clearance – In the last 10 years, FDA has cleared around 100 mobile medical apps – Includes about 40 in the last 2 years • Increasing need for certainty – Clarify limits of regulation – Encourage mobile medical app development – Oversee safety and effectiveness Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Background • Officially, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) • Issued September 25, 2013 • Similar to the July 19, 2011 draft version, but with many improvements • Product of extensive comments and FDA research • Explains the FDA’s oversight of mobile medical apps as devices • Not intended to expand the FDA’s universe, but to apply longstanding tenets of medical device regulation to apps • Guidance document (not legally binding) • Template for compliance Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly.” Dr. Jeffrey Shuren, FDA, Director for Radiological Health Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave Devices and
    • Mobile Medical App Guidance Overview • Focus is on apps that present a greater risk to patients • Distinguishes among several categories of mobile apps – Not medical devices (not regulated) – May be medical devices (but will be subject to "enforcement discretion") – Are medical devices (and will be regulated) • Focus is on apps, not platforms • Not just about what is regulated – significant guidance as to what apps are not regulated Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Focus on Mobile App Manufacturers • Guidance applies to “mobile medical app manufacturers” • Under the FD&C Act, being deemed a medical device “manufacturer” has potentially significant consequences – Medical device reporting when malfunctions, injuries or deaths occur (21 C.F.R. Part 803) – Reporting of device corrections or removals (21 C.F.R. Part 806); – Establishment registration and listing and premarket notification (510(k)) (21 C.F.R. Part 807) – Quality Systems/Good Manufacturing Practice requirements (21 C.F.R. Part 820) • No surprise then that the Guidance applies to mobile medical app “manufacturers” Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Focus on Mobile App Manufacturers • Provides examples of a mobile medical app “manufacturer” – Creates, designs, develops, or labels – Initiates specifications or requirements – Procures product development services • Includes specific exclusions and boundaries too – Excludes mere distributors, including app store operators and mobile platform makers – Distinguishes between “authors” of specifications and “developers” who implement those specifications • Particular focus on authority – those involved in design, development, or creation Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Apps Are Regulated as Medical Devices • Section 201(h) of the FD&C Act defines a medical “device” • Guidance clarifies that apps are subject to potential FDA regulation if they meet the definition of a “device” Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance “When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.” FDA Mobile App Guidance (Section III.C.) Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Only a Subset of Apps Are Subject to Regulation • FDA’s intention is to focus oversight on the subset of mobile apps that meets the definition of device and are: – Intended to be used as an accessory to a regulated medical device (e.g., an app that provides the ability to control inflation and deflation of a blood pressure cuff through a mobile platform) – Intended to transform a mobile platform into a regulated medical device (e.g, an app intended to analyze and interpret EKG waveforms to detect heart function irregularities) • Focus is on – Function of the mobile app (not the mobile platform) – Intended use of the mobile app – Risk to patient safety if the app were to malfunction • Labeling claims, advertising materials, and statements by manufacturers (or their reps) are instructive Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Guidelines Create Categories of Apps • Guidelines separate apps into three categories: (1) Apps that do not meet the statutory definition of a device and thus are not subject to FDA oversight (2) Apps that may meet the statutory definition of a device, but present such a low risk of patient harm that the FDA is not going to exercise oversight (“enforcement discretion”) (3) Apps that do meet the statutory definition of a device, and present potential patient risks warranting FDA oversight • Numerous examples provided in the Guidelines • Still not always an easy analysis Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Examples: Apps That Are NOT Medical Devices • Intended to provide electronic “copies” of medical textbooks or other reference materials with generic text search capabilities • Intended for health care providers to use as educational tools for medical training or to reinforce training previously received • Intended for general patient education and facilitate patient access to commonly used reference information • Automate general office operations in a health care setting • Generic aids or general purpose products • Provided that none of the foregoing are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Examples: Apps Subject to Exercise Enforcement Discretion • Provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment • Provide patients with simple tools to organize and track their health information • Provide easy access to information related to a patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference) • Specifically marketed to help patients document, show or communicate to providers potential medical conditions • Perform simple calculations routinely used in clinical practice • Enable individuals to interact with personal health record systems or electronic health record systems Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Examples: Apps Subject to FDA Regulatory Oversight • Extensions of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing or transmitting patient-specific medical device data • Transform the mobile platform into a regulated medical device by using attachments, display screens or sensors or by including functionalities similar to those of currently regulated medical devices • Become a regulated medical device (software) by performing patientspecific analysis and providing patient-specific diagnosis, or treatment recommendations (i.e., similar to or perform the same function as those types of software devices previously cleared or approved) Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Significance of Regulation • Regulated medical devices are divided into three classes: – Class I - General Controls – Class II - Special Controls in Addition to General Controls – Class III - Premarket Approval • Classes determine the level of control exercised by FDA • Controls take the form of premarketing and postmarketing submissions, applications, and approvals required for FDA clearance to market a device • If an app falls within a medical device classification, the manufacturer is subject to the requirements associated with that classification • Must meet the same requirements any other manufacturer of a device in that classification must meet Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Recommendations for Other Apps • Strong recommendation that manufacturers of any app that meets the definition of a “device”: – Follow FDA’s Quality System regulation (which includes good manufacturing practices) in the design and development of the app – Initiate prompt corrections to apps, when appropriate, to prevent patient and user harm • FDA research found that the majority of software-related device failures are due to design errors (including basic failures to validate software prior to routine production) Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Scope and Limitations • Guidelines only cover FDA regulation of mobile apps • Mobile apps are (potentially) subject to many other forms of regulation – FDA published important guidance regarding interoperability for mobile health devices (i.e., hardware) in August, 2013 – Federal Trade Commission (FTC) has investigated and taken action as far back as 2011 against mobile medical apps for false advertising – FTC has also been extremely active in data privacy and security enforcement, including in particular guidance covering mobile apps – HIPAA and HI-TECH Act specifically regulate protected health information, including on mobile apps • This can (very) challenging – even for medical device companies • Do not go it alone Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Mobile Medical App Guidance Where to Next? • FDA has reserved the right to issue additional guidance (as always) • Congressman Marsha Blackburn (R-TN07) led a bi-partisan team to that introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (HR 3303) on October 22nd • Intended to build on the Guidance by amending the FD&C Act • Offers definitions to differentiate “medical software” (i.e., regulated) from “clinical software” and “health software” (i.e., not regulated) • Seeks to: – Provide (additional) clarity – Focus authority on products that pose a potential risk to human health – Better define FDA regulatory authority over medical software – Provide better understanding of what applications require review and approval Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave
    • Thank You. Jason Haislmaier jason.haislmaier@bryancave.com @haislmaier http://www.linkedin.com/in/haislmaier Copyright 2013 BryanCave LLP Copyright 2013 BryanCave LLP Copyright 2012 Bryan Cave