Covidien - FDA Guidance on Mobile Medical Apps 140124

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 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
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Mobile Apps

Mobile
Apps


The FDA

U.S. Food and Drug Administration (FDA)
www.fda.gov


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”


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/


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


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



“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


Devices

and

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


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”


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


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”


“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.)


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

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


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


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


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)


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


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)


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


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


Thank You.
Jason Haislmaier
jason.haislmaier@bryancave.com
@haislmaier
http://www.linkedin.com/in/haislmaier


Covidien - FDA Guidance on Mobile Medical Apps 140124

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Covidien - FDA Guidance on Mobile Medical Apps 140124