Health care entrepreneurs have described the FDA as a barrier to the market. Most of the time companies do not know when the FDA is regulating their app, device, or software. With new hands-off policies instituted to promote innovations to the market, Bakul will provide insights on the FDA's plans to regulating health technology as well as protecting the patients who are using the products.

1. Digital Health
FDA as a partner in advancing health care
for patients

2. Digitization Across the Health Care Continuum
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Leveraging computing power, sensors, connectivity and software
Moving healthcare from the
Clinic to the Patient
Understanding patient’s
behavior and physiology “In
the wild”
Focusing on prevention for
early/smaller interventions

3. Smart Regulation Principles
Risk Based
Functionality Focused
Platform
Independent
Promote
Innovation
Narrowly
Tailored
Promote Patient
Engagement
Protect Patient
Safety
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4. Focusing on Higher Risk
Functionality
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Higher risk functionality
Appropriately oversee to assure patient safety
while considering advances in technology and
product life-cycle
• Engaging stakeholders
• Implementing policies
• Raising staff expertise and knowledge
Lower risk
functionality
Don’t intend to enforce
regulatory requirements

5. What did you
design it do?
• What is it for?
• Who is it for?
• When is it used?
“Intended for use” – A two part question
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What do you
say about it?
• What is it for?
• Who is it for?
• When is it used?
“Intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals”

6. What did you
design it do?
• What is it for?
• Who is it for?
• When is it used?
“Intended for use” – A two part question
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What do you
say about it?
• What is it for?
• Who is it for?
• When is it used?
“Intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals”
“Intended Use”

7. Digital Health Foundational Policies
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RFWireless-guidance
Mobilemedicalapp
(MMA)
FDASIAHealthITreport
Premarket
Cybersecurity
MDDS/image
storageand
communication
Generalwellness
Accessories
Interoperability
Post-market
cybersecurity
MMAupdate

8. Approach to Mobile Apps
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No regulatory
requirements
• Patient self-management apps
• Tools to organize and track their health information
(not for treating or adjusting medications)
• Tools to access to health information document and
communicate with health care providers
• Tools that automate simple health care providers
tasks
Enforcement Discretion
Mobile apps not
considered
“medical devices”
MMA
Lower risk
mobile apps that
meet “device” definition
but not considered “MMA”
Mobile apps that meet “device”
definition that are either intended
• To be used as an accessory to already
regulated medical device,
or
• To transform a mobile platform into a
regulated medical device.
focus of
oversight

9. Examples of Mobile Apps which are not considered MMA
Mobile apps –
NOT Medical Devices
• Library of clinical descriptions
• Medical flash cards
• Certification or recertification preparation apps;
• Games to train health professionals in advanced CPR
skills.
• Allow users to input pill shape, color or imprint and
displays pictures and names of pills that match this
description;
• Find the closest medical facilities;
• Help guide patients to ask appropriate questions to
their physician
• Track, review and pay medical claims and bills online;
• Manage or schedule hospital rooms or bed space
Mobile apps –
NOT Focus of Oversight
• 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.
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10. Mobile Medical Apps (MMA)
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“mobile medical app” is 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
Examples in Section V-A + Appendix C
MMA
focus of
oversight

11. Wearable Technologies

12. Fitness Wearable Example – Not Regulated
• Activity Sensors
• Measures HR and activity
• Intended to maintain/encourage a healthy lifestyle
• HR is used to assess level of exertion

13. Example
K152954 - Quell
• Quell is intended for use as a
transcutaneous electrical nerve
stimulation (TENS) device for temporary
relief of pain associated with sore and
aching muscles in the lower extremities
due to strain from exercise or normal
household and work activities.
• Quell is intended for use as a
transcutaneous electrical nerve
stimulation device for the symptomatic
relief and management of chronic
intractable pain.

14. General Wellness Devices
• Final Guidance Published July 29, 2016
– Defines General Wellness Products as those which meet the following two factors:
• Intended for only general wellness use
• Present a very low risk to users safety
– https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo
cuments/UCM429674.pdf
• Proposes a policy that
- Does not intend to examine low risk general wellness products to determine whether they are
“devices” within the meaning of the FD&C Act, or
- If they are “devices”, FDA does not intend to enforce compliance to regulatory requirements
for devices under the FD&C Act

15. The products FDA regulates…
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16. A risk based approach for medical devices
since 1976
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Class I
•General Controls
Class II
•General controls
•Special controls
Class III
•General controls
•Premarket approval (PMA)
Increasing Risk
Classification determines extent of regulatory control (Risk Based)
General Controls
•Electronic Establishment Registration
•Electronic Device Listing
•Quality Systems
•Labeling
•Medical Device Reporting (MDR)
•Premarket Notification [510(k)] (unless exempt)
Special Controls (addressing Risk)
•Guidelines (e.g., Glove Manual)
•Mandatory Performance Standard
•Recommendations or Other Actions
•Special Labeling (e.g., 882.5970, Cranial Orthosis)

17. Regulatory Tools
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•What is the device
•Who is the Manufacturer
Registration and Listing
Premarket Notification 510(k),
or
Premarket Approval (PMA),
•Confidential independent review prior to
commercial distribution
•Provide cross product lessons learned
Investigational Device Exemption (IDE)
for clinical studies
•Allowing new technology creation
Quality System (QS) regulation
•Non prescriptive principles for good
engineering and manufacturing
•Scalable for technology
Labeling requirements
•Establishes clear user
expectations
Medical Device Reporting
(MDR)
•Understand device issues and
impact on patients
Compliance program
•Correct defective product consistently
•Periodic monitoring to assure device quality is sustained

18. Quality Management Principles
A grouping of QMS activities from a Software perspective
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.docx

19. Resources
• 513(g)
• Pre-submission
• Digital Health and Mobile Apps email
– DigitalHealth@fda.hhs.gov
– MobileMedicalApps@fda.hhs.gov
• CDRH websites
– Digital health page
• http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm
– 510(k) database with Summaries

20. Reimagining a new paradigm
Fostering Medical Innovation: A Plan for Digital Health Devices
FDA commissioners Blog – 6/15/2017
By: Scott Gottlieb, M.D.
…….. In addition to these efforts, we are also announcing today a new initiative that
FDA is undertaking. This fall, as part of a comprehensive approach to the regulation of
digital health tools and in collaboration with our customers, FDA will pilot an entirely
new approach toward regulating this technology. This will be the cornerstone to a
more efficient, risk-based regulatory framework for overseeing these medical
technologies. ……
https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/
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21. In summary
• FDA excited to participate in promoting evidenced based safe
innovation for a better healthcare system
• FDA is interested in advancing patient safety and protecting patient
information is the cornerstone of a better healthcare system
W O R K TO G E T H E R
R E A C H A L L PAT I E N T S
B E T T E R T R E AT M E N T S A N D O U TC O M E S
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