Mobile Medical Applications Draft Guidance; Public Workshop, 50231-50233 [2011-20574]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
recommendations on January 19, 2011
(https://www.fda.gov/downloads/
AboutFDA/CentersOffices/CDRH/
CDRHReports/UCM239450.pdf ).
The second prong of the
comprehensive assessment of the 510(k)
process was an independent study by
the IOM. At the request of FDA, IOM
evaluated the 510(k) clearance process
and made recommendations aimed at
protecting the health of the public and
making available a mechanism to
achieve timely access of medical
devices to the market. On July 29, 2011,
IOM released the report ‘‘Medical
Devices and the Public’s Health, The
FDA 510(k) Clearance Process at 35
Years’’ (report) (https://www.iom.edu/
Reports/2011/Medical-Devices-and-thePublics-Health-The-FDA–510kClearance-Process-at-35–Years.aspx).
The report contains eight
recommendations aimed at improving
regulation of medical devices. The
recommendations are the subject of this
public meeting.
II. What are the specific issues for
discussion and public comment at the
public meeting?
FDA welcomes comments on the
following recommendations provided in
the IOM report:
1. The Food and Drug Administration
should obtain adequate information to
inform the design of a new medical
device regulatory framework for class II
devices so that the current 510(k)
process, in which the standard for
clearance is substantial equivalence to
previously cleared devices, can be
replaced with an integrated premarket
and postmarket regulatory framework
that effectively provides a reasonable
assurance of safety and effectiveness
throughout the device life cycle. Once
adequate information is available to
design an appropriate medical device
regulatory framework, Congress should
enact legislation to do so.
2. FDA should develop and
implement a comprehensive strategy to
collect, analyze, and act on medical
device postmarket performance
information.
3. FDA should review its postmarket
regulatory authorities for medical
devices to identify existing limitations
on their use and to determine how the
limitations can be addressed.
4. FDA should investigate the
viability of a modified de novo process
as a mechanism for evaluating the safety
and effectiveness of class II devices.
5. FDA should develop and
implement a program of continuous
quality improvement to track regulatory
decisions on medical devices, identify
potential process improvements in the
VerDate Mar<15>2010
16:37 Aug 11, 2011
Jkt 223001
medical device regulatory framework,
and address emerging issues that affect
decisionmaking.
6. FDA should commission an
assessment to determine the effect of its
regulatory process for class II devices on
facilitating or inhibiting innovation in
the medical device industry.
7. FDA should develop procedures
that ensure the safety and effectiveness
of software used in devices, software
used as devices, and software used as a
tool in producing devices.
8. FDA should promptly call for PMA
applications for or reclassify class III
devices that remain eligible for 510(k)
clearance.
III. Where can I find out more about
this public meeting?
Background information on the public
meeting, registration information, the
agenda, information about lodging,
transcripts, and other relevant
information will be posted, as it
becomes available, on the Internet at
https://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 https://
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 hardcopy
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. 2011–20575 Filed 8–11–11; 8:45 am]
BILLING CODE 4160–01–P
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.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
50231
Notice of public workshop;
request for comments.
ACTION:
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
SUMMARY:
E:\FR\FM\12AUN1.SGM
12AUN1
50232
Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
requirements. To register for the public
workshop—whether attending in person
or for the webcast—please visit https://
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
https://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
VerDate Mar<15>2010
16:37 Aug 11, 2011
Jkt 223001
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 (https://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:
• 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.
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 * * *’’.
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.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12AUN1.SGM
12AUN1
50233
Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
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 standalone 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
https://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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Web-Based Skills
Training for SBIRT (Screening Brief
Intervention and Referral to Treatment)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
May 24, 2011, Vol 76, #100, page
30177–30178, and allowed 60 days for
public comment. One request for the
draft instruments was received from the
public. These were provided to the
requestor. The purpose of this notice is
SUMMARY:
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection
Title: Web-based Skills Training for
SBIRT (Screening Brief Intervention and
Referral to Treatment).
Type of Information Collection
Request: NEW.
Need and Use of Information
Collection: The project aims to increase
the provision of screening, brief
intervention, and referral to treatment
(SBIRT) for substance use in primary
care by developing an engaging,
interactive case-based training program
that will be delivered over the Internet,
providing convenient access to
screening and brief intervention skills
training and resources for busy PCPs.
The goal of this study is to evaluate the
effectiveness of this training on provider
behavior and/or patient outcome and
the program’s utility as a training tool in
a real-world medical setting. The
training is named SBIRT–PC. Study
participants will be randomly assigned
to complete SBIRT–PC or a control
training, consisting of online reading
materials. Effectiveness will be
evaluated in terms of differential SBIRTrelated knowledge, attitudes, selfefficacy, self-reported clinical practices,
skills as measured by virtual
standardized patient evaluations (VSPE)
and a telephone-based standardized
patient (SP) interaction. Participants in
each condition will also complete a
training satisfaction questionnaire.
Frequency of Response: On occasion.
Affected Public: Private sector;
businesses or other for-profit.
Type of Respondents: Primary Care
Providers.
The annual reporting burden is as
follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of respondents
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Average
burden
hours per
set of
responses
Estimated
total annual
burden hours
requested
Primary Care Providers ...................................................................................
94
1
2.0
188
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
VerDate Mar<15>2010
16:37 Aug 11, 2011
Jkt 223001
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 50232]]
requirements. To register for the public workshop--whether attending in
person or for the webcast--please visit https://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 https://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 (https://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:
---------------------------------------------------------------------------
\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 * * *''.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 50233]]
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 https://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 https://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
