This document provides guidance on mobile medical apps according to draft guidelines from the US Food and Drug Administration (FDA). It discusses the FDA's proposed definition of mobile medical apps and scope of regulation. Certain types of apps, such as those solely for general health and wellness, would not be regulated. The document also discusses who would be considered the manufacturer of a mobile medical app and provides comments on the FDA's draft guidelines, calling for clearer definitions and exemptions for low-risk products. Further steps from the FDA and developments in the EU are also outlined.

1. MOBILE MEDICAL
APPS GUIDANCE
Medica Erik Vollebregt
17 November 2011 www.axonadvocaten.nl

2. There’s an app for that
• More and more decision support goes to the handheld
• E.g. for interpretation of diagnostic results
• eHealth / Telemedicine- new paradigms, new problems
• EU harmonisation initiatives for law and standards
• Increasing convergence between consumer electronics and medical
devices
• Kinect in the operation theatre, Wii balance board for biofeedback

3. US draft guidance mobile medical
apps
• The FDA proposes that the guidance is applicable to mobile medical
applications or “mobile medical apps”, defined as
• “a software application that can be executed (run) on a mobile
platform, or a web-based software application that is tailored to a
mobile platform but is executed on a server”; and
• has an intended use within the scope of the concept of medical
„device‟ as regulated by the FDA; and
• are used as an accessory to a regulated medical device; or
• transform a mobile platform into a regulated medical device.

4. FDA proposes no medical apps
are:
• “electronic “copies” of medical textbooks, teaching aids or reference
materials, or are solely used to provide clinicians with training or reinforce
training previously received.
• apps that are solely used to log, record, track, evaluate, or make
decisions or suggestions related to developing or maintaining general
health and wellness, provided that they are not intended for curing,
treating, seeking treatment for mitigating, or diagnosing a specific
disease, disorder, patient state, or any specific, identifiable health
condition.
• possible borderline problems in EU as no „general health and
wellness‟ exempted category exists under MDD
• apps that are generic aids that assist users but are not commercially
marketed for a specific medical indication, such as recording audio, note-
taking, replaying audio with amplification, and other similar functionalities.
• apps that perform the functionality of an electronic health record system
or personal health record system.

5. Who is manufacturer?
• In the US the party that:
• Creates, designs, develops, labels, re-labels, remanufactures,
modifies, or creates a software system from multiple components;
• Provides mobile medical app functionality through a “web service” or
“web support” for use on a mobile platform;
• Initiates specifications or requirements for mobile medical apps or
procures product development/manufacturing services from other
individuals or entities (second party) for subsequent commercial
distribution;
• Creates a mobile medical app intended to be used on a mobile
platform, or that manufactures a mobile app to be supported by
hardware attachments to the mobile platform with a device intended
use.

6. Comments on FDA draft guidelines
• Intended use approach leads to too broad scope and is not clear enough;
FDA should specify positively the intended uses that trigger regulation
• Define “health and wellness”
• Impact of consumer use versus professional use in regulation
• Low risk products should be exempted
• Normal accessory rule problematic in mobile and electronic health
scenarios, because risk profile of these accessories is not necessarily
the same as parent device
• More guidance needed for roles and responsibilities of other parties
involved in the manufacturing (vendors), network services (ISPs) and
distribution (app stores)
• Provide for modularisation of software and software specific classification
rules

7. Further steps FDA
• ~ 90 submissions received on draft guidelines, some very substantial
(100+ pages)
• FDA is expected to come out with definite guidance somewhere in Q1
2012
• Subsequent project for FDA guidance: Clinical Decision Support Systems
(CDS)

8. EU developments
• Standalone software MEDDEV more or less finished – to be published in
December 2011
• Next edition of Manual on Borderline and Classification expected to
contain some software borderline guidance
• Recast developments
• Expectation that Recast will include more direct supply chain actor
responsibilities, like in new Toy Directive and Cosmetics Directive
• Borderline solution via (likely) EMA

9. Start
MEDDEV decision tree No
general 1.Is the SW a computer program?
Yes
• Software No No
3. SW performs action that is
decision tree different from storage, archival,
lossless compression, simple
search?
2. Is the SW embedded in MD?
as per EU
draft Yes Yes, then
regulated
as part
MEDDEV on No
4. Software is for benefit of
individual patient(s)?
of device
standalone Yes
software Yes
5.Action in scope of intended use
under MDD regulated in MDD?
• Caution: final No
version may No
6. Accessory to MD?
Yes
differ
Out of scope MDD In scope of MDD

10. Thank you for your attention
Erik Vollebregt
Axon Advocaten
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonadvocaten.nl
T @meddevlegal
B http://medicaldeviceslegal.com