[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50231-50233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20574]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0530]
Mobile Medical Applications Draft Guidance; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Mobile Medical Applications Draft Guidance.'' The
purpose of the workshop is to provide a forum for discussion with FDA
and to encourage public comment on the following topics: FDA's recently
issued draft guidance document entitled ``Mobile Medical
Applications,'' how FDA should approach accessories and particularly
mobile medical applications that are accessories to other medical
devices, and standalone software that provides clinical decision
support.
Date and Time: The public workshop will be held on September 12 and
13, 2011. Submit electronic and written comments by October 19, 2011.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (rm. 1503), Silver Spring, MD 20993-0002.
Contact Person: Bakul Patel, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5456, Silver Spring, MD 20993, 301-796-5528,
Bakul.Patel@fda.hhs.gov.
Registration and Requests for Oral Presentations: Registration is
free and will be on a first-come, first-served basis. Persons
interested in attending this workshop must register online by 5 p.m. on
September 9, 2011. For those without Internet access, please call the
contact person to register.
Early registration is recommended because seating is limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided beginning at 7:30 a.m. Non-U.S.
citizens are subject to additional security screening, and they should
register as soon as possible.
If you need special accommodations due to a disability, please
contact Susan Monahan (e-mail: Susan.Monahan@fda.hhs.gov or phone: 301-
796-5661) no later than September 9, 2011.
This workshop will also be provided via webcast. Persons interested
in participating by webcast must register online by 5 p.m. on September
9, 2011. Early registration is recommended because webcast connections
are limited. Organizations are requested to register all participants,
but view using one connection per location. Webcast participants will
be sent connection
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requirements. To register for the public workshop--whether attending in
person or for the webcast--please visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to
the FDA Medical Devices News & Events--Workshops & Conferences calendar
and select this public workshop from the posted events list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, e-mail, telephone, and FAX number.
Registrants will receive confirmation once they have been accepted. You
will be notified if you are on a waitlist.
This workshop includes a public comment session. During online
registration you may indicate if you wish to make an oral presentation
during a public comment session at the public workshop, and which topic
you wish to address in your presentation. FDA has included topics for
comment in this document. FDA will do its best to accommodate requests
to speak. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin. All requests to make oral presentations, as well as presentation
materials, must be sent to the contact person by September 9, 2011.
Comments: Regardless of attendance at the public workshop,
interested persons may submit either electronic or written comments
until October 19, 2011. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
SUPPLEMENTARY INFORMATION:
I. What is the background and purpose for holding this public workshop?
The purpose of the workshop is to provide a forum for discussion
with FDA and to encourage public comment from interested stakeholders
on the following issues previously raised in the notice of availability
for the draft guidance (76 FR 43689, July 21, 2011): FDA's recently-
issued draft guidance document entitled ``Mobile Medical
Applications,'' how FDA should approach accessories and particularly
mobile medical applications that are accessories to other medical
devices, and stand-alone software that provides clinical decision
support.
Given the rapid expansion and broad applicability of mobile
applications (mobile apps), FDA issued the draft guidance, ``Mobile
Medical Applications'' on July 21, 2011, to clarify the types of mobile
apps to which the FDA intends to apply its authority (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm).
At this time, FDA intends to apply its regulatory requirements to a
subset of mobile apps that the Agency is calling mobile medical
applications (mobile medical apps). For purposes of the draft guidance
and the public workshop discussion, a ``mobile medical app'' is a
mobile application that meets the definition of ``device'' in section
201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 321(h)) \1\; and either:
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\1\ Products that are built with or consist of computer and/or
software components or applications are subject to regulation as
devices when they meet the definition of a device in section 201(h)
of the FD&C Act. That provision defines a device as ``* * * an
instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent * * *'', that is ``* * * intended for use in the
diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man * * * '' or
``* * * intended to affect the structure or any function of the body
of man or other animals * * *''.
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Is used as an accessory to a regulated medical device; or
Transforms a mobile platform into a regulated medical
device.
This narrowly-tailored approach focuses on a subset of mobile apps
that either have traditionally been considered medical devices or
affect the performance or functionality of a currently regulated
medical device.
Although some mobile apps that do not meet the definition of a
mobile medical app may meet the FD&C Act's definition of a device, FDA
intends to exercise enforcement discretion \2\ towards those mobile
apps.
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\2\ This means that FDA intends to exercise its discretion to
decline to pursue enforcement actions for violations of the FD&C Act
and applicable regulations by a manufacturer of a mobile medical
app, as specified in the draft guidance, ``Mobile Medical
Applications.'' This does not constitute a change in the
requirements of the FD&C Act or any applicable regulations.
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II. What are the specific issues for discussion and public comment at
the public workshop?
We welcome comments on all aspects of the draft guidance as well as
the following specific issues:
1. FDA generally considers extensions of medical devices as
accessories to those medical devices. Accessories have been typically
regulated under the same classification as the connected medical
device. However, we recognize potential limitations to this policy for
mobile medical apps. FDA seeks comment on how the Agency should
approach accessories and particularly mobile medical apps that are
accessories to other medical devices so safety and effectiveness can be
reasonably assured. For example, one possible approach could be the
following:
An accessory that does not change the intended use of the
connected device, but aids in the use of the connected medical device
could be regulated as class I. For example, such an accessory would be
similar to an infusion pump stand, which is currently classified as a
class I device because it supports the intended use of an infusion pump
(class II medical device). A mobile medical app that simply supports
the intended use of a regulated medical device could be classified as
class I with design controls as part of the quality systems
requirements;
An accessory that extends the intended use of the
connected medical device could be classified with the connected device.
For example, if a mobile medical app that performs more detailed
analysis than the connected medical device while maintaining the
original intended use, which is data analysis, could be classified in
the same classification as the connected medical device; and
An accessory that creates a new intended use from that of
the connected device(s) could be classified according to the risk posed
to patient safety by the new intended use, for example, if the intended
use of a mobile medical app is to provide prognosis relating to a
certain disease or condition and the mobile medical app is connected to
a device that does not have that intended use, the mobile medical app
may have a different level of risk than the connected device, resulting
in a different classification to assure safety and effectiveness of the
mobile medical app.
2. FDA has not addressed in its draft guidance, ``Mobile Medical
Applications,'' stand-alone software (mobile or traditional
workstation) that analyzes, processes, or interprets medical device
data (collected
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electronically or through manual entry of the device data) for purposes
of automatically assessing patient specific data or for providing
support in making clinical decisions. FDA plans to address such stand-
alone software in a separate guidance. In order to provide a reasonable
assurance of the safety and effectiveness of such software, and to
ensure consistency between the draft guidance, ``Mobile Medical
Applications,'' and the planned guidance on stand-alone software that
provides clinical decision support (CDS), FDA is seeking comment on the
following issues:
What factors should FDA consider in determining the risk
classification of different types of software that provide CDS
functionality? Please provide examples of how those factors would be
applied for such software that you believe should be in class I, class
II, and class III;
How should the FDA assess stand-alone software that
provides CDS functionality, to assure reasonable safety and
effectiveness? For example, to what extent can FDA rely on a
manufacturer's demonstration that it has a robust quality system with
appropriate quality assurance and design controls? Under what
circumstances should the submission of clinical data be required?; and
Are there specific controls that manufacturers should
implement that could change the risk classification or reduce the
premarket data requirements for particular types of stand-alone
software that provide CDS functionality?
III. Where can I find out more about this public workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, transcripts, and
other relevant information will be posted, as it becomes available, on
the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
IV. Will there be transcripts of the meeting?
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: August 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20574 Filed 8-11-11; 8:45 am]
BILLING CODE 4160-01-P