Transcript The Food and Drug Administration

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. [email protected]
•
•
•
•
© 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.
2
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
© Morgan, Lewis & Bockius LLP
3
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
© Morgan, Lewis & Bockius LLP
4
What is a Medical Device?
• “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
© Morgan, Lewis & Bockius LLP
5
What is a Medical Device?
• “Safe and Effective”
• Class I devices are low risk
• Class II devices are moderate risk
• Class III devices are high risk
© Morgan, Lewis & Bockius LLP
6
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
© Morgan, Lewis & Bockius LLP
Class I
Class II
7
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
© Morgan, Lewis & Bockius LLP
8
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
© Morgan, Lewis & Bockius LLP
9
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
–
–
–
• 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
© Morgan, Lewis & Bockius LLP
10
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”
© Morgan, Lewis & Bockius LLP
11
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)
© Morgan, Lewis & Bockius LLP
12
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
© Morgan, Lewis & Bockius LLP
13
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
© Morgan, Lewis & Bockius LLP
14
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
© Morgan, Lewis & Bockius LLP
15
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).
© Morgan, Lewis & Bockius LLP
16
Manufacturer Responsibilities
• Establishment registration and device listing
• Quality System Regulation
• Labeling
• Medical Device Reporting
• Corrections and Removals Reports
© Morgan, Lewis & Bockius LLP
17
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?
© Morgan, Lewis & Bockius LLP
18
Considerations and Actions
•
•
•
•
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
© Morgan, Lewis & Bockius LLP
19
Questions?
Thank you!
© Morgan, Lewis & Bockius LLP
20
international presence
Almaty Beijing Boston Brussels Chicago Dallas Frankfurt Harrisburg Houston Irvine
London Los Angeles Miami Moscow New York Palo Alto Paris Philadelphia Pittsburgh
© Morgan, Lewis & Bockius LLP
Princeton
San Francisco Tokyo Washington 21 Wilmington