June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.

1. ComplianceOnline Medical Device Summit 2018
Recent FDA Developments in
Digital Health & Clinical Decision
Support Software
Michael A. Swit, Esq.
Managing Principal, Law Offices of Michael A. Swit

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Standard Disclaimers
➢ Views expressed here are solely mine and do not reflect
those of my law firm or any of its clients.
➢ This presentation supports an oral briefing and should
not be relied upon solely on its own to support any
conclusion of law or fact.
➢ This presentation, and the materials included herewith,
are provided for general educational purposes and
should not be construed as legal advice.

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➢ Added New Section 520(o) of Federal Food, Drug,
and Cosmetic Act (“the Act”)
➢ Key provisions -- excluded from “medical device”
definition in § 201(h) of Act -- five types of software
– health care facility software
– “wellness” software
– electronic patient records
– medical device data transferring
– certain “clinical decision support software” or “CDS”
21st Century Cures Act

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➢ 520(o)(1)(A)
“… for administrative support of a health care facility,
including the processing and maintenance of financial records,
claims or billing information, appointment schedules, business
analytics, information about patient populations, admissions,
practice and inventory management, analysis of historical claims
data to predict future utilization or cost-effectiveness,
determination of health benefit eligibility, population health
management, and laboratory workflow;”
Healthcare Facility Software

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➢ 520(o)(1)(B)
– ‘‘… for maintaining or encouraging a healthy lifestyle and is
unrelated to the diagnosis, cure, mitigation, prevention, or
treatment of a disease or condition;
Wellness/Lifestyle Software

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➢ 520(o)(1)(C)
– ‘‘ … to serve as electronic patient records, including patient-provided
information, to the extent that such records are intended to transfer,
store, convert formats, or display the equivalent of a paper medical
chart, so long as—
‘‘(i) such records were created, stored, transferred, or reviewed by health care
professionals, or by individuals working under supervision of such professionals;
‘‘(ii) such records are part of health information technology that is certified under
section 3001(c)(5) of the Public Health Service Act; and
“(ii) such function is not intended to interpret or analyze patient records, including
medical image data, for the purpose of the diagnosis, cure, mitigation, prevention,
or treatment of a disease or condition;
Electronic Patient Records

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➢ 520(o)(1)(D)
– for transferring, storing, converting formats, or displaying
clinical laboratory test or other device data and results, findings
by a health care professional with respect to such data and
results, general information about such findings, and
general background information about such laboratory test
or other device, unless such function is intended to
interpret or analyze clinical laboratory test or other device
data, results, and findings;
Medical Device Data Transferring

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➢ Must NOT be intended to acquire, process, or analyze a medical
image or signal from an in vitro diagnostic device or a pattern or
signal from a signal acquisition system, for the purpose of—
• (i) displaying, analyzing, or printing medical information about a patient or other
medical information (such as peer-reviewed studies and clinical practice guidelines);
• (ii) supporting or providing recommendations to a health care professional about
prevention, diagnosis, or treatment of a disease or condition; and
• (iii) 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.
Clinical Decision Support Software
(in certain circumstances, not a device)

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➢ Commissioner Gottlieb:
– “our approach to regulating these novel, swiftly evolving
products must foster, not inhibit, innovation. Moreover, we
must always lean in the direction of enhancing access to more
information – not restricting information flow – given the
ability of reliable information to positively impact daily life.”
• Statement, December 7, 2017
– Link:
https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf
FDA – Digital Health Innovation
Action Plan

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➢ Three key aspects
– Increase number and sophistication of FDA staff addressing D.H.
issues
– Digital Health Software Precertification Program
• 9 companies
• Conference at end of Jan. 2018
• https://www.fda.gov/MedicalDevices/DigitalHealth/UCM567265
– Implement Cures Act
Digital Health Innovation
Action Plan

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➢ Draft Guidance – 12/17
– Differentiates CDS as:
• not a medical device
• is a medical device, but subject to enforcement discretion (E.D..?)
• is a medical device and FDA will regulate
– Parses the language of 520(o)(1)(E) – added by Cures Act -- in
detail as to factors impacting if all 4 criteria (see Slide 8) are
satisfied
• if any of criteria are not met, the CDS is regulated by FDA
Clinical Decision Support Software

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➢ Not a device – software that:
– gives recommendations to health care providers (HCPs) by
matching patient-specific info (e.g., signs, symptoms, allergies,
diagnoses) to routine reference info (e.g., practice guidelines)
– gives HCPs recommendations on how to use a Rx drug in a
manner consistent with approved labeling (my emphasis)
– is intended for use by HCPs to aid in diagnosing diabetes
mellitus – enter various parameters (e.g., fasting plasma glucose)
and software suggests if patient has diabetes per guidelines.
Examples of the 3 “Types” of CDS

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➢ Is a device; enforcement discretion – software that:
– [none listed]
Examples of the 3 “Types” of CDS

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➢ Is a device subject to regulation – software that:
– uses a patient’s image sets to create an individual treatment plan
and HCP relies primarily on software’s recommendations in
finalizing the plan
– that analyzes multiple physiological signals (e.g., sweat, heart
rate, eye movement, etc., -- from FDA-regulated devices) to
monitor if person is having a heart attack
– calculates the fractal dimension of a lesion and surrounding
skin image and builds a structural map to provide diagnosis or
identify if lesion is benign or malignant
Examples of the 3 “Types” of CDS

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➢ FDA will exercise enforcement discretion if a PDS
meets all these factors:
– doesn’t acquire, process or analyze a medical image or signal from an IVD or
signal acquisition system;
– “display, analyze, or print medical information about a patient or other medical
information” (such as from peer-reviewed clinical studies and clinical practice
guidelines);
– support or provide recommendation to patients or non-HCP caregivers about
prevention, diagnosis, or treatment of a disease or condition; and
– enables the patient or non-HCP caregiver to independently review the basis for
the recommendation so that it is not the intent that such patient/caregiver rely
primarily on such recommendation to make a decision
Patient Decision Support Software (PDS)

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➢ Last factor – independent review – software should
clearly explain:
– purpose or intended use of the software function;
– who the intended user is (e.g., patient, non-HCP caregiver)
– inputs used to generate the recommendation (e.g., age and gender)
– rationale or support for the recommendation
➢ In short, the intended user should be able to reach a decision on
their own without primarily relying on the software function
➢ Parallels the HCP CDS factors
Patient Decision Support Software (PDS)

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➢ Examples of a PDS subject to enforcement discretion:
– software that reminds a patient to take a drug per its labeling
– software that assists patient in choosing an appropriate OTC drug
➢ Example of a PDS subject to regulation:
– Software takes a home bloods test result and makes a recommendation for
warfarin dosing (e.g., after calculating the INR).
Patient Decision Support Software (PDS)

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➢ Cures Act – if one function of a product is not a
medical device (e.g., heart rate monitor) and other
function is a medical device,
– FDA may not regulate the non-med device function as a
medical device, BUT
– may consider impact of non-medical device function on how
the device function should be regulated
➢ Draft Guidance (4/18)
Multiple Function Devices

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➢ Software as a Medical Device (SAMD) – Clinical
Evaluation (12/17)
➢ Changes to Medical Device Software in a 510(k) (10/17)
➢ Changes to a 510(k) (10/17)
➢ Mobile Medical Applications (2/15)
➢ General Wellness Device (7/16)
Other Guidances

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➢ Call or e-mail:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
➢ Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
Questions?

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Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues since 1984. Before
returning to private law practice in late 2017, he served for 3 years at Illumina, Inc. as Senior Director, Legal,
Regulatory. Prior to that, Swit was a special counsel at the global law firm of Duane Morris LLP in its San
Diego office. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at
The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His
expertise includes product development, compliance and enforcement, recalls and crisis management,
submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research
efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics and therapeutic
biotech products. His FDA legal and regulatory work also has included tenures in private practice with
McKenna & Cuneo (now Dentons) and Heller Ehrman, and as vice president, general counsel and secretary
of Par Pharmaceutical, a top public generic and specialty drug firm. He also was, from 1994 to 1998, CEO
of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for
FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated
commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory
University.
About Your Speaker

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