Mobile Medical Applications The FDA Regulatory Approach

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Geneva, Switzerland, 25
26 September 2012

Mobile Medical Applications

The FDA Regulatory Approach

Prof. Lucien Rapp,

Avocat au Barreau de Paris,

Watson, Farley & Williams LLP

ITU Experts Group Meeting on m
Health: Towards
Better Care, Cure and Prevention in Europe

Geneva, Switzerland, 25
26 September 2012

The FDA’s Path

1989 : FDA preparing a general policy statement : «

Software Policy

» (withdrawn in 2005)

2011 (Feb.15) : FDA regulation down
classifying certain
or software
based devices (MMDS

Device Data Systems) from Class III (high
risk) to Class I

2011 (July 21) : FDA issuing its
Draft Guidance on Mobile
Medical Applications

2012 (July 31) :
FDA Safety and Innovation Act

(including the MDUFA

Medical Device User Fee
Amendment III)

2012 (December) : the FDA to finalize its MMA Guidelines

The FDA Approach of MMA

Medical apps include a
variety of functions
, ranging from
assisting individuals in their own health and wellness
improving and facilitating the delivery of
patient care

500 millions smartphone users worldwide will be using a
healthcare application
by 2015

The use of mobile medical apps is
healthcare delivery

The draft approach calls for oversight of only the medical
apps that present the
greatest risk to patients

when they
do not work as intended

The FDA recognises the extensive variety of
actual and
potential functions

of mobile apps, the rapid
pace of

in mobile apps and
potential benefices


to public health

The Scope of the FDA’s

Draft Guidance on MMA

The agency’s draft guidance defines
a small subset of
mobile medical apps

that impact or may impact the
performance functionnality of currently regulated
medical devices

The subset includes medical apps that

are used as an accessory to medical device already
regulated by the FDA (for example, an application that
allows a health care professional to make a specific
diagnosis by viewing a medical image on smart phone or
mobile tablet

transforms a mobile platform into a regulated medical
device (for example an application that
turns a
smartphone into an ECG machine to detect abnormal
heart rhythms

From Mobile Products

to Medical Devices


Mobile platform

defined as
commercial off
computing platforms with or
without a wireless connectivity
that are handled in nature (ex.
mobile computers such as I
Phone, Blackberry phones, Android
phones, tablet computers,
personal digital assistants)

Regulated Medical Device

as a product that definition in
section 201(h) of the Federal Food
Drug and Cosmetic Act and that
has been classified, cleared or
approved or cleared by the FDA



Mobile app (
software application
that be run on a mobile platform
or a web
based software
application that is tailored to a
mobile platform but is executed on
a server

Which meets the definition of [a
medical] «


»; and either,

is used as an accessory to a
regulated medical device ; or,

transforms a mobile platform into a
regulated medical device


Mobile apps that are
electronic copies of medical textbook,
teaching aids or reference materials

(do not contain any
specific information/ show examples for a specific
medical specialty ; ex. flashcards or quizzes)

Mobile apps that
are solely used to log, record, track,
evaluate or make decision or suggestions relating to
developing or maintaining general health and wellness

intended for curing, treating or seeking treatment ; ex.
dietary tracking logs, appointment reminders or dietary or
posture suggestions)

Mobile apps that only
automate general office operations

(billing, inventory, appointments or insurance transactions)

Mobile apps that are
generic aids that assist users

but are
not commercially marketed for a specific medical indication
(ex. magnifying glass, recording audio, note

Mobile apps that
perform the functionnality of an electronic
health record system

MMA Manufacturer

Defined as
any person or entity

that manufactures mobile medical

Excludes any entity that

mobile apps
without engaging in
manufacturing functions (ex.
owners and operators of Android
market, iTunes store, BlaclBerry
App World)

The FDA expects that distributors
to cooperate with the regulated
apps developers
in the event of a
correction or a recall

Includes any person or entity that
creates designs, develops, labels,
relabels, remanufactures or
creates a software system from
multiple components

(ex. a person
that uses commercial off
the shelf
software components and market
the product to perform as a mobile
medical app)

Includes any person that
mobile medical app functionnality
through a web
service or web
support for use on a mobile

(ex. a manufacturer that
allows users to access the
application’s medical device
functionnality over the web)

Includes any person that
specifications or requirements for
mobile medical apps or procures
product development/
manufacturing services

(ex. a

Regulatory Approach for MMA

Based on a device classification into three
classes I, II and II (requirements described
in the applicable device classification

Class I (General controls : registration, QOS
regulation, labelling requirements, reporting
corrections and removal)

Class II (General controls + premarket

Class III (General controls + premarket

five requests to the FDA

Clarify the difference between a medical app and a wellness app
(ex.exercise apps that measures how many miles I run in a given

Clarify the difference between diagnosing and monitoring (ex.
apps that offer a photo galery of skin conditions)

Establish the risk level threshold for FDA enforcement (ex. apps
that functions as a simple calculator for an infant’s Apgar score)

Define the limits of the FDA’s rule on apps that serve as device
accessories (ex. apps that display the blood pressure reading)

Make a plan for how to handle «


» apps ( programs that
work together to form a health
management system either by
sharing data with each other or by controling one another ; ex.
diabetes app that takes data from patient’s glucose meter, that
borrows the data and tells what I should have for lunch, that helps
to order insulin from my pharmacy)

Conclusions and Recommendations

The EU regulatory
environment is way behind
in terms of sophistication
and level of details

The reasoning of the FDA
fits into the EU regulatory
system (ex. Exclusions :
largely similar under EU

going need to
harmonize and coordinate
efforts accross the world

The EU should use FDA
Guidance to its advantage
to take a much
and due step in the
clarification of its
regulation of software
under the MDD


Geneva, Switzerland, 25
26 September 2012