[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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Mobile Medical 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 FDA is issuing this draft guidance to inform 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 This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 19, 2011

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Mobile Medical Applications'' to the 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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