[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43689-43690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18537]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0530]
Draft Guidance for Industry and Food and Drug Administration
Staff; Mobile Medical Applications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Mobile Medical
Applications.'' FDA is issuing this draft guidance to inform
manufacturers, distributors, and other entities about how the FDA
intends to apply its regulatory authorities to select software
applications intended for use on mobile platforms (mobile applications
or ``mobile apps''). At this time, FDA intends to apply its regulatory
requirements solely to a subset of mobile apps that the Agency is
calling mobile medical applications (mobile medical apps). This draft
guidance is not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 19, 2011
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Mobile Medical Applications'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health (CDRH), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
For devices regulated by CDRH: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-5528.
For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.
I. Background
Given the rapid expansion and broad applicability of mobile apps,
FDA is issuing this draft guidance to clarify the types of mobile apps
to which FDA intends to apply its authority. At this time, FDA intends
to apply its regulatory requirements to a subset of mobile apps that
the Agency is calling mobile medical apps. For purposes of this
guidance, a ``mobile medical app'' is defined as a mobile app 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); \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 mobile
medical app may meet the FD&C Act's definition of a device, the 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 this guidance. This does not constitute a
change in the requirements of the FD&C Act or any applicable
regulations.
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We welcome comments on all aspects of this 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 comments 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.
An accessory that creates a new intended use from that of
the connected
[[Page 43690]]
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 of safety and effectiveness of the
mobile medical app.
2. FDA has not addressed in this guidance stand-alone software
(mobile or traditional workstation) that analyzes, processes, or
interprets medical device data (collected 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 this guidance and the planned guidance on stand-alone software
that provides clinical decision support (CDS), FDA is seeking comments
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 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?
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?
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on mobile
medical applications. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at either http://www.regulations.gov or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Mobile Medical Applications'' from CDRH, you may either send an e-
mail request to [email protected] to receive an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1741 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 801 are approved under OMB control number 0910-0485; the
collection of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; the collections of information in 21 CFR part
806 are approved under OMB control number 0910-0359; the collections of
information in 21 CFR part 807, subpart B, are approved under OMB
control number 0910-0387; the collections of information in 21 CFR part
807, subpart E, are approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 820 are approved under
OMB control number 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. 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.
Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18537 Filed 7-19-11; 4:15 pm]
BILLING CODE 4160-01-P