This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include: * FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff * Determination of whether a mobile app is a medical device subject to FDA enforcement action * Scope of FDA’s regulatory discretion regarding mobile apps * FDA’s conflicting guidance on dosage apps * How to meet key requirements of promotional labeling in mobile programs * The growing area of mobile apps as promotional messaging platforms This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics. The framework flow chart shown in this presentation is available here: http://ow.ly/qMxse

1. Regulatory Considerations in
Mobile Programs
Presented by Dale Cooke & Geoff McCleary
13 November 2013

2. Agenda
> Rise & importance of mobile
> FDA mobile apps guidance
> An open question
> Mobile medical device requirements
> Promotional labeling in mobile tactics
> Q&A
2

3. Rise & importance of mobile
3

4. Vatican,
2005

5. Vatican,
2013

6. Source: KPCB

7. 91% of smartphone owners have
their phone within arm’s length most
of the time. (60% all the time)
7
www.marketingcharts.com/direct/most-smartphone-owners-feel-naked-without-their-devices-21769

8. 8
blog.newrelic.com/wp-content/uploads/mobile_ig_final1.png

9. of ALL children
under two,
9
are using mobile
http://www.commonsensemedia.org/research/zero-to-eight-childrens-media-use-in-america-2013

10. Mobile
DRIVES
%
of all internet traffic
10

11. 52% OF SMARTPHONE OWNERS
GATHER HEALTH INFO ON THEIR
MOBILE DEVICE
http://pewinternet.org/~/media/Files/Reports/2012/PIP_MobileHealth2012.pdf

12. 9 out of 10 would “take” an app if a
physician prescribed it.

13. Building a study to learn more…
> Survey 2000+ consumers to find out how they use smartphones to
access disease related health information and services now, and
what they want to access in the future.
> We asked patients and caregiver across 20 diseases in 5 categories
•
•
•
•
•
Allergy & Asthma
Cardiologic Conditions
Neurologic Conditions
Diabetes
Gastroenterological Conditions
> Demographic profiles
•
Age, income, marital status, location, etc
> Condition Profiles
•
Disease, impact, treatment type, activity at physician’s office
> mHealth Use
•
use by disease category, device type, location, future needs

14. STUDY REPORT:
Consumer Use of Smartphones for
Condition Related Health Activities
Prepared by
14

15. FDA mobile apps guidance
15

16. What is this thing?
Advertising &
Promotion
16
Medical Devices

17. FDA is here to help
Released September 2013
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/UCM263366.pdf
See also, http://www.scribd.com/doc/170875173/DH-Regulatory-AlertMobile-App-Guidance-Finalized
17

18. MMA guidance
Mobile Medical App (MMA) defined as:
“a mobile app that meets the definition of device in
section 201(h) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act); and either is intended:
• to be used as an accessory to a regulated medical
device; or
• to transform a mobile platform into a regulated
medical device.”
—FDA
18
Guidance for Industry: Mobile Medical Applications, page 7

19. Digitas Health is also here to help
19

20. CDRH will focus its regulatory efforts on apps that:
> Are accessories to a regulated medical device
> Transform the mobile device into a medical device
> Perform patient-specific analysis and provide patientspecific treatment recommendations
20

21. 21

22. 22

23. CDRH will focus its regulatory efforts on apps that:
> Are accessories to a regulated medical device
> Transform the mobile device into a medical device
> Perform patient-specific analysis and provide patientspecific treatment recommendations
23

24. “Some mobile apps may meet the definition
of a medical device but because they pose
a lower risk to the public, FDA intends to
exercise enforcement discretion over these
devices (meaning it will not enforce
requirements under the FD&C Act)”
—FDA Guidance for Industry: Mobile Medical Applications, page 4
24

25. Regulatory discretion
FDA is asserting two things:
1. FDA has the legal authority to enforce legal and
regulatory requirements in that area.
2. FDA will not use that authority.
25

26. Will FDA change its position?
—FDA Mobile Apps Twitter Chat, September 26, 2013
26

27. •
Help patients (i.e., users) self-manage their disease or conditions
without providing specific treatment or treatment suggestions;
•
Provide patients with simple tools to organize and track their
health information;
•
Provide easy access to information related to patients’ health
conditions or treatments;
•
Help patients document, show, or communicate potential medical
conditions to health care providers;
•
Automate simple tasks for health care providers; or
•
Enable patients or providers to interact with Personal Health
Record (PHR) or Electronic Health Record (EHR) systems.
—FDA Guidance for Industry: Mobile Medical Applications, page 16
27

28. 28

29. 29

30. 30

31. An open question
31

32. What about dosing apps?
“apps that use patient-specific parameters and calculate
dosage or create a dosage plan for radiation therapy” ARE
devices where FDA will require presubmission, etc.
—FDA Guidance for Industry: Mobile Medical Applications, page 15
But…
“Mobile apps that perform simple calculations routinely
used in clinical practice” ARE devices where FDA will
NOT require presubmission, etc.
—FDA Guidance for Industry: Mobile Medical Applications, page 17
32

33. Some will not be subject to enforcement
—FDA Mobile Apps Twitter Chat, September 26, 2013
33

34. Medical device requirements
34

35. Meeting medical device requirements
> Medical device manufacturer registration
> Class determination (I, II, or III)
> Validated development environment and/or
quality systems in place
> Investigational Device Exemption filing
requirements
> 510(k) or PMA filing with FDA likely required
> Postmarketing reporting requirements
35

36. Promotional labeling in mobile
tactics
36

37. Mobile apps as promotional platforms
Mobile apps can be advertising platforms (e.g., The New York Times
app, Doximity)
When the underlying app discusses health, the same rules apply
> Is it a medical device?
> Does regulatory discretion apply?
> Is your paid placement an advertisement or part of the app’s core
functionality?
37

38. Promotional labeling requirements
Four Types of Communication
Product Promotion Requirements
> Reminder Ads
> Product Name Usage
> Product Promotions
> Fair Balance
> Disease Awareness
Communications
> Indication Statement
> Redirecting Communications
> Adequate Provision
(Directions for Use)
> MedWatch Statement
> Beware turning your app
into a regulated device via
promotion!
38

39. But what about mobile promotion?
Unique considerations for mobile promotion
> Device size
> Device variability
> Screen rotation
> Technology changes (Go away, Flash!)
> Screen takeover
> Touch screen interface
> Integration with the rest of the device (GPS, calendar,
reminders, accelerometer, etc.)
39

40. Questions?
Dale Cooke
Vice President/Group Director, Regulatory Review
Dale.Cooke@DigitasHealth.com
@PhillyCooke on Twitter
www.scribd.com/Dale_Cooke

41. About the speaker:
Dale Cooke, VP/Group Director, Regulatory
Dale Cooke is the head of the regulatory department for Digitas Health. He
has worked with more than 30 pharmaceutical and medical device clients and
with Medical-Legal-Regulatory committees around the world from offices in
Philadelphia, New York, Boston, San Francisco, and London. Dale advises
clients on FDA enforcement actions and provides recommendations for
compliance with FDA regulations, with a focus on issues involving the Internet
and emerging technology. His insights have been featured in the Wall Street
Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others.
Dale is an active member of the Regulatory Affairs Professionals Society
(RAPS), Drug Information Association (DIA), and the Food and Drug Law
Institute (FDLI).
Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI primer series. He is regularly invited to speak
at industry conferences on topics including FDA enforcement trends, best
practices for review processes, global review practices, and pharmaceutical
involvement in social media.
Dale earned his B.A. in Philosophy from Southern Methodist University and an
M.A. in Analytical Philosophy from the University of Arizona and studied
Epidemiology and Biostatistics at Drexel University’s School of Public Health.
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42. Geoff McCleary
Vice President/Group Director, Mobile Innovations
As group director of mobile innovation at Digitas Health, Geoff is responsible
for all mobile channel strategy and oversight of mobile efforts globally for
Digitas Health work across multiple offices for major pharmaceutical,
healthcare, and biotech clients.
Before joining the company in 2012, Geoff was head of strategy for mobile
healthcare marketing agency Eveo. With responsibility for development of
strategy, research and planning practices for an organization with over 40
healthcare apps in the app store.
Prior to Eveo, Geoff was the VP Strategy for imc2 Health & Wellness,
developing strategic vision and direction for the company’s east coast
pharmaceutical clients. In addition, he was lead for the company’s Mobile
Center of Excellence, providing mobile marketing consulting to major CPG
brands as well as existing healthcare clients.
More than 15 years of pharmaceutical and interactive marketing experience
enables him to provide the most strategic mobile and technological insights
to the world’s largest pharmaceutical clients. As a leading mobile marketing
evangelist, Geoff has established himself as a proponent of using mobile
tools, social media and emerging technologies to creative meaningful
connections with patients, consumers and physicians.
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