[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Mobile Medical Applications Draft Guidance; Public Workshop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workshop entitled: ``Mobile Medical Applications Draft Guidance.''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issued draft guidance document entitled ``Mobile Medical 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 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:
---------------------------------------------------------------------------

    \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 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