Covidien - FDA Guidance on Mobile Medical Apps 140124

Copyright 2012 Bryan Cave Copyright 2013 BryanCave LLP Copyright 2013 BryanCave LLP

January 24, 2014

Jason D. Haislmaier

[email protected]

Final FDA Guidance for

Mobile Medical App Developers and

Food and Drug Administration Staff

Copyright 2014 Jason D. Haislmaier

Copyright 2012 Bryan Cave Copyright 2013 BryanCave LLP

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Mobile

Apps

Mobile Apps


U.S. Food and Drug Administration (FDA)

www.fda.gov

The FDA


• 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”

Federal Food, Drug, and Cosmetic (FD&C) Act

FDA Authority


• 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/

History of FDA Scrutiny

Mobile Medical Applications


• 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

Many Drivers for FDA Concern

Mobile Medical Applications


• 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

Background

Mobile Medical App Guidance


Dr. Jeffrey Shuren,

FDA, Director for Devices and

Radiological Health

“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.”



• 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

Overview



• 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

Focus on Mobile App Manufacturers



• 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”

Apps Are Regulated as Medical Devices



FDA Mobile App Guidance

(Section III.C.)

“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’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

Only a Subset of Apps Are Subject to Regulation



• 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

Guidelines Create Categories of Apps



• 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 That Are NOT Medical Devices



• 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 Exercise Enforcement Discretion



• 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 patient-

specific 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)

Examples: Apps Subject to FDA Regulatory Oversight



• 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

Significance of Regulation



• 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)

Recommendations for Other Apps



• 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

Scope and Limitations



• 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

Where to Next?


Copyright 2012 Bryan Cave Copyright 2013 BryanCave LLP Copyright 2013 BryanCave LLP

Thank You.

Jason Haislmaier [email protected]

@haislmaier

http://www.linkedin.com/in/haislmaier