This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each. The FDA Guidance Documents to be discussed: • Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 • Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 • Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

1. Allison C. Komiyama, PhD, RAC
akomiyama@acknowledge-rs.com
AcKnowledge-RS.com
Digital Health and Remote
Monitoring Devices: the Impact of
COVID-19 on Their Regulation

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3. AcKnowledge-RS.com

6. https://www.fda.gov/about-fda/virtual-exhibits-fda-history/history-fdas-role-preventing-spread
-hivaids

7. https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emit
ting-products/cdrh-proposed-guidances-fiscal-year-2020-fy-2020

8. Pandemic Pontifications
► What do recent guidance documents tell us?
► Where are they coming from?
► What are digital health devices and how are they used?
► How do we measure benefit and risk in times of COVID-19?
► Where do we go from here?
► How do things go back to “normal”?

9. https://www.fda.gov/regulatory-information/search-fda-guidance-documents

10. https://www.fda.gov/media/136290/download

11. https://beta.regulations.gov/ Docket: FDA-2020-D-1138-0001
Introduction to Remote Monitoring

12. Devices covered in this guidance

13. Policy
► “FDA does not intend to object to limited modifications
to the indications, claims, functionality, or hardware or
software of FDA cleared non-invasive remote
monitoring devices that are used to support patient
monitoring”
► Examples of such modifications include:
► The inclusion of monitoring statements related to patients with
COVID-19 or co-existing conditions (such as hypertension or heart
failure);
► For subject devices previously cleared only for use in hospitals or
other health care facilities, a change to the indications or claims
regarding use in the home setting; and
► Hardware or software changes to allow for increased remote
monitoring capability.”

14. A. Modifications to FDA-cleared
Indications, Claims, or Functionality
► “FDA does not intend to object to modifications to the FDA-cleared
indications, claims, or functionality of the subject devices without prior
submission of a premarket notification where the modification does
not create an undue risk in light of the public health emergency. FDA
currently believes a modification does not create such undue risk in the
following scenario:
1) The device is intended for the purpose of displaying, printing or analyzing the
physiological parameter(s) measured by the device; and
2) The device is intended for the purpose of supporting or providing adjunctive
recommendations to the health care professional or patient about prevention,
diagnosis or treatment of COVID-19 or co-existing conditions; and
3) The health care provider and/or patient can independently review the basis for
any diagnostic or treatment recommendations.”

15. Examples of Indication Expansion
https://www.mobihealthnews.com/news/vitalpatch-granted-eua-monitoring-covid-19-patients-q
t-intervals
https://www.massdevice.com/coala-life-launches-expanded-covid-19-remote-patient-monitorin
g-capabilities/

16. B. Modifications to FDA-cleared Hardware or
Software Intended to Increase Remote
Monitoring Availability or Capability
► “FDA does not intend to object to hardware or software architecture
modifications to subject devices that allow for increased remote
monitoring capability to support additional claims or indications without
prior submission of a premarket notification…where the modifications do
not directly affect the physiological parameter measurement algorithms.
One example is the addition of wireless and/or Bluetooth capability.”

17. C. Clinical Decision Support Software for
Monitoring related to COVID-19 and
Co-existing Conditions
► “Software, including mobile apps, may be useful in connection with
monitoring for patients with COVID-19 or co-existing conditions and
providing clinical decision support.”
1. NOT intended to acquire, process, or analyze a medical image or a signal from
an in vitro diagnostic device or a pattern or signal from a signal acquisition;
2. 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;
3. intended for the purpose of supporting or providing recommendations to a
health care professional about prevention, diagnosis, or treatment of a disease or
condition; and
4. 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

18. Examples of CDS
https://www.covid19healthtech.com/companies

19. https://www.fda.gov/media/136939/download

20. https://beta.regulations.gov/ Docket: FDA-2020-D-1138
Introduction to Digital Health
Therapeutic Devices
CDRH-COVID19-DigitalHealthForPsychiatricDisorders@fda.hhs.gov

21. A. Computerized Behavioral Therapy devices
and other digital health therapeutic devices
for psychiatric disorders
► “As defined in 21 CFR 882.5801, a computerized behavioral therapy
device for psychiatric disorders is a Class II, prescription only, device
(product code PWE) intended to provide a computerized version of
condition-specific behavioral therapy as an adjunct to clinician supervised
outpatient treatment to patients with psychiatric conditions.
► Digital health therapeutic devices for psychiatric disorders that operate
using a different fundamental technology than computerized
behavioral therapy and would not fit within the scope of 21 CFR
882.5801, but are intended to treat patients with psychiatric
conditions are also subject to the policies in this guidance.
► In addition, variations of computerized behavioral therapy devices that
are outside the scope of 21 CFR 882.5801, such as non-prescription
devices, are also subject to the policies in this guidance.”

22. Examples of PWE devices
https://peartherapeutics.com/

23. B. Low-risk general wellness and digital
health products for mental health or
psychiatric conditions.
► “For the purposes of this guidance, and consistent with FDA’s General
Wellness and Software Functions and Mobile Medical Applications
guidances, “general wellness products” are products that may meet the
definition of a device under section 201(h) of the FD&C Act and (1) are
intended for only general wellness use, as explained in the General
Wellness Guidance, and (2) present a low risk to the safety of users and
other persons.”

24. Enforcement Discretion
► “Given these public health benefits, for the duration of the COVID-19
public health emergency, FDA does not intend to object to the
distribution and use of computerized behavioral therapy devices and
other digital health therapeutic devices for psychiatric disorders,
which are described in Section III.A, without compliance with the
following regulatory requirements, as applicable, where such devices do
not create an undue risk in light of the public health emergency:
► Submission of a premarket notification under section 510(k) of the FD&C Act and 21
CFR 807.81
► Reports of Corrections and Removals requirements in 21 CFR 80
► Registration and Listing requirements in 21 CFR Part 807
► Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR
801.20.”

25. Enforcement Discretion
► “Additionally, for computerized behavioral therapy devices for psychiatric
disorders subject to this policy, FDA does not intend to enforce
compliance with the special controls identified in 21 CFR 882.5801,
which include the requirement of prospective clinical data, to assist
with more efficient access to these devices in light of the public health
emergency
► Where the software products with low-risk general wellness…FDA does
not intend to enforce applicable regulatory requirements in line with
existing policies described in FDA’s General Wellness and Software
Functions and Mobile Medical Applications8 guidances.
► FDA does not regulate software for videoconferencing, even when
intended for use in telemedicine, because software intended for video
communication is not a medical device.”

26. https://www.fda.gov/media/136733/download

27. https://www.fda.gov/media/137286/download

28. https://www.fda.gov/media/137307/download

29. Pandemic Pontifications
► What do recent guidance documents tell us?
► Where are they coming from?
► What are digital health devices and how are they used?
► How do we measure benefit and risk in times of COVID-19?
► Where do we go from here?
► How do things go back to “normal”?

30. Thank you!
Allison C. Komiyama, PhD, RAC
akomiyama@acknowledge-rs.com
AcKnowledge-RS.com