Presentation by Bethany Hills, Partner, Mintz Levin: Digital Health Regulation and the FDA. Includes overview of the 21st Century Cures Act, Definition of a medical device, device approval basics, software as a Medical Device (SaMD), FDA Digital Health Activities, mobile medical applications, regulated mobile medical applications, Enforcement discretions of MMA, Clinical Decision Support, 3060 Clarifying Health Software Regulation, Classification Process,

1. Digital Health – Innovation Driving FDA Regulation
Bethany Hills, JD/MPH

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Bethany J. Hills, JD/MPH
Chair, FDA Practice
Mintz Levin, NYC

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Mintz 21st Century Cures Series
• Part I: Introduction and Context
• Part II: The Impact of Cures on
Clinical Research
• Part III: The Impact of Cures on the
FDA
• Part IV: Combination Product
Pathways and Policy (APRIL)
On Tuesday, December 13th, President Obama signed in to law
the 21st Century Cures Act, days after it overwhelmingly passed
in the US House of Representatives and Senate. This significant
piece of bipartisan legislation will have a sweeping impact on
health care providers, researchers, and pharmaceutical and
medical device manufacturers. At nearly 1000 pages in length,
the Act supports and funds the discovery, development, and
delivery of new drugs and medical treatments; it also amends
HIPAA, and includes substantial mental health and Medicare
delivery reforms.

4. • Section 201(h) of the Federal Food, Drug, and Cosmetic Act, defines a medical
device as:
– "... an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component, part, or
accessory, which is ... [either]
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 ... [or]
intended to affect the structure or any function of the body of man or other
animals."
• Accessory built into general definition
• Intended use turns on claims, statements (written or oral), actions, and other
circumstances of the manufacturer
What is (and is not) a medical device?
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5. • Exempt Product (Class I) – Registration and listing of device, no pre-market
approval (notice w/in 30 days of market)
– Low Cost
– On Market Quickly
• Medium Risk (Class II) – 510(k), pre-market notification (“clearance”),
substantial equivalence to predicate device (90 day FDA review time –
usually longer)
– Cost $10,000-$50,000
– Avg. 1 year to market
• High Risk (Class III) – Pre-Market Approval (PMA), requires demonstration
of safety and effectiveness (done through clinical studies)
– Cost $200,000-$1,000,000+
– Avg 3-5+ years to market
Device Approval Basics
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6. Software as a Medical Device
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7. • FDA adopts policy passed by International Medical Device Regulatory Forum
(IMDRF).
– FDA intends to consider the principles of this guidance in the development of
regulatory approaches for SaMD and digital health technologies.
• There is a valid clinical association between the output of a SaMD and the
targeted clinical condition (to include pathological process or state); and
• That the SaMD provides the expected technical and clinical data.
Specific aspect of Verification and Validation
SaMD Software As a Medical Device (Dec. 2017 Final
Guidance)
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8. • Digital Health Innovation Plan –
https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.
pdf
– Clarify 21st Century Cures changes to FDA policy
– Launch pre-certification program [allows FDA to certify an organization and
expedite new SaMD product with streamlined pre-market review; increase use of
NEST; consider third-party certifications]
– FDA improving internal knowledge and on digital health – Focused Digital Health
Program/Unit
• Medical Device Innovation Consortium (MDIC), a 501(c)(3) public-private
partnership, is serving as an independent coordinating center that operates
National Evaluation System for health Technology (NEST)
• Finalize Guidance on when to submit a new 510(k) for modifications of SaMD
products
FDA Digital Health Activities
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9. Mobile medical apps (MMA)
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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
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10. 1. Accessories to a medical device
– Mobile apps that are an “extension” to a medical device by connecting to the
device to control the device or display, store, analyze, or transmit patient-specific
medical device data
2. Functionalities similar to currently regulated medical devices
a. Using special medical attachments
b. Using generic attachments
c. Using no attachments
3. Clinical Decision Support
a. performing patient-specific analysis and
b. providing patient-specific diagnosis, or treatment recommendations.
Regulated Mobile Medical Apps
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11. Mobile Medical Apps
MMA Not an MMA Enforcement Discretion
• Accessories
• Transform the mobile
platform
• Patient Specific
Analysis (21st C Cures?)
• Electronic copies of
medical textbooks
• Educational tools
• Facilitate patient
access to information
• General operations in
healthcare settings
(accounting, billing)
• Generic aid (e.g.
magnifying glass)
Electronic health record
General health and
wellness
• Patient motivation
• Patient daytimers
• Access to contextually
relevant information
• Certain telemedicine
products
• Simple professional
calculators
• Connections to EHRs
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12. Recent Classifications of MMA
• Pear Therapeutics (Sept. 2017)
• Computerized behavioral therapy device for psychiatric
disorders. A computerized behavioral therapy device for psychiatric
disorders is a prescription device intended to provide a computerized
version of condition-specific behavioral therapy as an adjunct to
clinician supervised outpatient treatment to patients with psychiatric
conditions. The digital therapy is intended to provide patients access
to therapy tools used during treatment sessions to improve
recognized treatment outcomes.
• NEW REGULATION NUMBER: 21 CFR 882.5801
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13. Clinical Decision Support (Draft Guidance)
To be exempt from FDA regulation, CDS software functions must be:
• not intended to acquire, process, or analyze a medical image or a signal from an in
vitro diagnostic device of a pattern or signal from a signal acquisition system (section
520(o)(1)(E) of the FD&C Act);
• intended for the purpose of displaying, analyzing, or printing medical information
about a patient or other medical information (such as peer-reviewed clinical studies
and clinical practice guidelines) (section 520(o)(1)(E)(i) of the FD&C Act);
• intended for the purpose of supporting or providing recommendations to a health
care professional about prevention, diagnosis, or treatment of a disease or condition
(section 520(o)(1)(E)(ii) of the FD&C Act); AND
• intended for the purpose of enabling such health care professional to independently
review the basis for such recommendations that such software presents so that it is
not the intent that such health care professional rely primarily on any of such
recommendations to make a clinical diagnosis or treatment decision regarding an
individual patient (section 520(o)(1)(E)(iii) of the FD&C Act).
RED = CDS Definition
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14. • 5 Types of Software Excluded from "device" definition
– Administrative support of health care facility (inc. lab workflow)
– Maintain or encourage a healthy lifestyle, unrelated to diagnosis, cure, mitigation,
prevention, or treatment of disease or condition
o FDA Wellness Guidance- unregulated
– Electronic patient records for transfer, store, convert formats, or display patient
information (do not "interpret or analyze")
o FDA Mobile Medical Applications Guidance- enforcement discretion
– Transfer, store, convert formats or display lab test or device data; OR
o FDA MDDS non-enforcement policy
– Decision Support Purposes
o Display information about a patient,
o Support or provide recommendations to a health professionals AND
o Enable HCP to independently review software recommendations
S. 3060 Clarifying Health Software Regulation
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15. Classification Process
• Any statutory classification?
– None Identified
• Existing Regulatory Classification?- Monitor for new classifications through
de novo process.
– 21 CFR 882.XXX
• FDA Policy?
– MMA Guidance – Used to help assess classification when no regulation exists or
assess a mobile version of a classified device
– CDS Draft Guidance – to clarify the statutory requirement for a group of CDS
software exempt for being a “medical device”

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Questions?
bjhills@mintz.com
212-692-6239(o)
212-222-0581(m)
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