This is a primer to get you thinking about whether or not your mobile health app is going to need FDA approval. If you are just tripping across the internet and found this, check the date, this was given before the FDA finalized their guidelines.

1. Does your Mobile App need
FDA Approval?
Cynthia Phelps
July 16, 2013

2. Why does the FDA care?
The FDA is charged with protecting and advancing
the public health
Food, Drug and Cosmetic Act of 1938
They regulate:
• Biologics (blood
supply), Cosmetics, Drugs, Food, Radiation
products, Veterinary Products AND
• Medical Devices

3. Software FDA regulates
Medical Device Software
Productions System Software
Quality System Software
Electronic Medical Records Software
Clinical Investigations Software

4. Classification
Products that are
clearly NOT
regulated by the
FDA
Medical Devices
ARE clearly
regulated by the
FDA
GREY AREA

5. Products not regulated
Not regulated:
• Hospital Network devices
• Data storage devices
• Computer Monitors
• Software that monitors device malfunction

6. Regulated Products
Medical Devices
ARE regulated
by the FDA

7. Regulated Products
Grey Area – FDA Guidelines
http://www.fda.gov/MedicalDevices/DeviceRegulationan
dGuidance/GuidanceDocuments/
Not yet approved by Congress

8. What is a Medical Device?
An
instrument, apparatus, implement, machine, contri
vance, implant, in vitro reagent, or similar or
related article, including any component, part, or
accessory, which is intended for the diagnosis, of
disease, or in the cure, mitigation, treatment, or
prevention of disease in man or animals, or
intended to affect the structure of function of the
body of man or animal.

9. Is your App a
Medical Device?
Does your App:
Amplify Cure
Analyze Detect
Interprets Diagnose
Assess Manipulate
Calculate Measure
Control Program
Convert Show trends?

10. What is the intended use?
Is it a part of an existing medical
device?
Is it an extension of a medical
device?
Does it diagnose, treat, mitigate, or
prevent a disease?

11. Mobile App Criteria
Extensions of Devices
Transform Apps to Devices
Data Input Devices

12. Extensions of Devices
Apps that serve as extensions of
regulated devices such as those that:
control the devices or
display data from the devices
Analyze data from the devices
Transmit data from these devices

13. Transform Apps to Devices
Apps that serve to transform mobile
platforms into medical control by
using:
Attachments
Similar medical device functions

14. Data Input Devices
Apps allow users to input patient
data to:
Output patient specific results, or
Diagnose
Using formulae or algorithms

15. OMG
Class I Class II Class III
OMG You
better have
stacks of
cash and a
boat load of
patience
It’s ok, you
can ride
someone’s
coattails
No worries
the FDA
have bigger
fish to fry
The Skinny

16. Class I Class II Class III
3+ Years
FDA review
PMA
application
2+ Months
FDA review
510(k)
application
No Formal
Review
Register
Online
Timeline & Process

17. Class III
• Highest risk
• Your app qualifies as a medical device
• There is no existing medical device precedent for
your App

18. Class II
• Medium Risk
• You app counts as a medical device
• There are other FDA approved medical devices like
yours

19. Class I
Lowest Risk
Your App is exempt from pre-market notification
requirements (510(k)) in the US
MDDS – Medical Device Data Systems (2001)
Category of devices used to transfer, store, convert, or display
medical device data.
No diagnosis or treatment
No altering the function or controlling the function of a medical
device

20. Device Classification
Go to:
www.fda.gov/medicaldevices
Go to:
Search bar, type in Product Classification
Enter a search term in the device field:
(Guess using the most general search term
possible)

21. FDA Guidelines not Final
FDA, ONC and FCC are developing a report to be
delivered to Congress by September that
includes:
“a strategy for coordinating the regulation of health information
technology in order to avoid regulatory duplication” and
“recommendations on an appropriate regulatory framework for
health information technology, including a risk-based framework.”
Discourage Innovation in Healthcare
Latest news: http://mobihealthnews.com/23305/final-days-of-
waiting-for-fda-mobile-medical-app-guidance/

22. FDA Scorecard
1. Number of FDA regulated medical apps reviewed to date: 100 mobile
medical apps to date (June 2013)
2. Time it takes for apps to get through 510(k): About 67 days for most mobile
medical apps.
3. Number of medical apps seeking clearance each year: FDA only reviews
about 20 mobile medical apps each year through its medical device
regulatory process.
4. No Class III mobile medical apps yet: The FDA has not found any mobile
medical apps to be Class III medical devices yet.
5. When will the final guidance on mobile medical apps be published? That’s a
good question, September.

23. HEALTHeDesigns LLC
Cynthia Phelps, PhD
Founder
HEALTHeDesigns@gmail.com
www.HEALTHeDesigns.com