FDA Regulations and Telehealth: Devices, Networks and Institutions

together
Mid-Atlantic Telehealth Resource
Center (MATRC) 2013 Summit

OVERCOMING POLICY CHALLENGES:
FDA Regulation of Telehealth:

Devices, Networks, and Institutions
Anthony T. (“Tony”) Pavel
Partner- Morgan, Lewis & Bockius LLP
FDA and Healthcare Practice Group
www.morganlewis.com

Presenter
Anthony T. Pavel
Washington, DC
tel. 202.739.5612
email. apavel@morganlewis.com
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© Morgan, Lewis & Bockius LLP

Tony Pavel is a Partner at Morgan Lewis & Bockius, whose practice centers FDA law and
medical devices
First job in law school – Intern with the then “Center for Telemedicine Law,” 1998
Currently on the Board of Directors, Robert J. Waters Center for Telehealth & e-Health
Law
Provide counsel to telehealth medical device manufacturers and telehealth networks.

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The Food and Drug Administration
– The Food and Drugs Act of 1906
• No Mention of Medical Devices

– The Federal Food, Drug, and Cosmetic Act of 1938
• Defined Devices, Adulteration and Misbranding

– The Medical Device Amendments of 1976
• Three-Tiered Classification System for Devices
• Notification (“510(k)”) or Approval (“PMA”) of Devices for
Marketing

• Quality Control Requirements

– Several other significant amendments since „76

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What is a Medical Device?
• Any instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar related article
• Intended for use in the diagnosis of disease or other conditions, or in
the cure, treatment, or prevention of disease, or intended to affect
the structure or function of the body
• Which does not achieve its principle purposes by chemical action in
or on the body of man or by being metabolized (i.e., not a drug).

– FDCA § 201(h), 21 U.S.C. § 321(h)
• VERY Broad definition

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• “Intended Use”
• Core concept in FDA law
• Authority to regulate revolves around the intended use
• “Intended for use in the diagnosis of disease or other
conditions, or in the cure, treatment, or prevention of disease,
or intended to affect the structure or function of the body”

• Intended use is determined by:
– Labels and “labeling” (including websites)
– Promotional material
– Oral representations

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• “Safe and Effective”
• Class I devices are low risk
• Class II devices are moderate risk
• Class III devices are high risk


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Some Core Telehealth Device Categories
Device Type
Medical device data systems
(MDDS)
Medical image
storage/communications
devices
PACS systems

Classification
Class I

Nurse call systems

Class II

Active Patient Monitoring

Class II or III

Clinical Decision Support

Generally Class II

Mobile Health Apps

Depends


Class I

Class II

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MDDS
 MDDS is a device that is intended to provide one or
more of the following uses, without controlling or altering
the functions or parameters of any connected medical
devices:
– The electronic transfer of medical device data;
– The electronic storage of medical device data;
– The electronic conversion of medical device data from
one format to another format in accordance with a
preset specification; or
– The electronic display of medical device data

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MDDS

 “Medical device data” is:
– “any electronic data that is available directly from a
medical device or that was obtained originally from a
medical device.”
 MDDS have limited intended uses (i.e., transmitting,
storing, converting according to a preset specification,
and displaying data) and do not add value to the data or
the devices with which they are used. “Conduit.”
 NO active patient monitoring or alarm functions

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What is Not MDDS?


General purpose IT infrastructure used in health care facilities that is not altered or reconfigured
outside of its manufactured specifications.



Components with the following functions by themselves are NOT considered MDDS if they are
used as part of general IT infrastructure even though they may transfer, store, display or convert
medical device data, in addition to other information:
– The electronic transfer of medical device data

–

–

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• Network Router
• Network Hub
• Wireless access point
The electronic storage of medical device data
• Network Attached Storage (NAS)
• Storage area network (SAN)
The electronic conversion of medical device data from one format to another in accordance
with a preset specification
• Virtualization System (ex. VM Ware)
• PDF software
The electronic display of medical device data
• Computer Monitor
• Big screen display


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The Gray Zone
• Off the shelf web cam (e.g. Logitech) Walmart/Office
Max or consumer camcorder being utilized for “clinical
telemedicine”
– Intended Use – what does the clinical telemed involve
– General video conferencing / communication?
– Urgent or Acute Care (Tele-Stroke) ?
– Diagnosis or communication as part of diagnosis?
– Camcorders attached to video unit to visualize wounds
• Note under the Act, an “accessory” to a medical device is
classified the same as the actual “device”

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Other Examples
• Computer to which an FDA-approved electronic
telemedicine stethoscope is connected to transmit
auscultated sounds
– The computer – probably not MDDS
– The software – probably will be MDDS

• FDA-approved telemedicine stethoscope with software
to record auscultated sounds and forward to a provider
(stethoscope/software designed to record and later
transmit sounds)
– Software will be MDDS (if not included in original
stethoscope FDA clearance)

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More Examples
• Consumer device- iphones, ipad, droid etc. example
blood glucose meters connected to these devices, data
downloaded to the cloud and pulled by practitioners to
make clinical decisions
– Software that is designed to transmit blood glucose data
through consumer devices is MDDS (at a minimum)

• Audio visual cart with in ports to connect peripherals
(e.g. exam camera connected to port by s video cable
which connects to the video conferencing unit codec)
– Everyone‟s favorite. If cart is designed and intended for
use with medical devices, FDA considers it a medical
device

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OK – When Do You Become a
“Manufacturer”
 “Manufacturing” is more than actual manufacture of a
device
 Activities that result in manufacturer responsibilities:
– Manufacture, preparation, propagation, compounding,
assembly, or processing of a medical device
– Repackaging to change the container, wrapper, or labeling
– Initial importation
– Initiation of device specifications


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Ex: Device Manufacturing – MDDS
 Firms that manufacture MDDS (design the specifications, develop
software, etc.)
 Any user of an MDDS (e.g., any individual, hospital, or corporation)
that makes “any modifications to the MDDS that are outside the
parameters of the original manufacturer‟s specifications for the
device, for purposes of the user‟s clinical practice or otherwise for
commercial use”
 A user who “reconfigures” a product into an MDDS device
 An entity that develops its own software protocols or interfaces “that
have an intended use consistent with an MDDS”

 An entity that creates a system “from multiple components of
devices and uses it clinically for functions covered by the MDDS
classification,” would also be considered to be a device
manufacturer

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Ex: Device Manufacturing – MDDS
 The FDA does not consider the following activities to be “
“manufacturing” an MDDS:
– Purchasing and using general purpose IT equipment/software or
infrastructure for purposes of interfacing with medical devices
and performing functionality described in the MDDS rule
(transfer, store, display, or convert data).
– Purchasing and using an MDDS marketed by an MDDS
manufacturer for purposes of interfacing with medical devices
and performing functionality described in the MDDS rule
(transfer, store, display, or convert data).


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Manufacturer Responsibilities
• Establishment registration and device listing
• Quality System Regulation

• Labeling
• Medical Device Reporting

• Corrections and Removals Reports

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Considerations and Actions
• Assessment of “home grown” telehealth tech
• Review
– Intended use
– Associated risk – compare to FDA‟s Definitions for Class
I,II & III
– What modifications are being made?
– “One off,” replicated, or marketed?


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Considerations and Actions
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FDA has limited resources
Some of these issues are difficult for the Agency
FDA understands how telehealth has evolved
FDA has enforcement discretion

• Other considerations
– Back to risk level
– Other liability


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Questions?

Thank you!


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