This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.

1. The Move to Mobile:
Strategies to Mitigate Regulatory
Concerns for Digital Platforms
Presented by Dale Cooke
8 October 2013

2. 2
Medical DevicesAdvertising &
Promotion
What is this thing?

3. 3
FDA is here to help
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/UCM263366.pdf
See also, http://www.scribd.com/doc/170875173/DH-Regulatory-Alert-
Mobile-App-Guidance-Finalized
Released September 2013

4. 4
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 Guidance for Industry: Mobile Medical Applications, page 7

5. 5
CDRH regulatory focus
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 patient-
specific treatment recommendations

6. 6
CDRH regulatory discretion
“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
Requirements of the FD&C Act include:
> Registration as a medical device manufacturer
> Premarket submission/approval
> Filing Medical Device Reports (MDRs)

7. 7
Will FDA change its position?
—FDA Mobile Apps Twitter Chat, September 26, 2013

8. 8
Scope of the discretion
• 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

9. 9
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.
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 15
—FDA Guidance for Industry: Mobile Medical Applications, page 17

10. 10
Some will not be subject to enforcement

11. 11
> Class determination
> Development environment
> 510(k) or PMA filing
with FDA likely required
> Medical device manufacturer registration
> Postmarketing reporting requirements
Meeting medical device requirements

12. 12
Promotional labeling requirements
Product Promotion Requirements
> Product Name Usage
> Fair Balance
> Indication Statement
> Adequate Provision
(Directions for Use)
> MedWatch Statement
> Beware turning your app
into a regulated device via
promotion!
Four Types of Communication
> Reminder Ads
> Product Promotions
> Disease Awareness
Communications
> Redirecting Communications

13. 13
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, etc.)

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

15. 15
Dale Cooke
VP/Group Director, Regulatory Review
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.