[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59038-59039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0530]


Mobile Medical Applications; Guidance for Industry and Food and 
Drug Administration Staff; 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 guidance entitled ``Mobile Medical Applications.'' 
The FDA is issuing this 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, the 
FDA intends to apply regulatory requirements to only a small subset of 
mobile apps referred to in this guidance as mobile medical applications 
(mobile medical apps).

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the 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, Suite 200N, 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 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, 
the FDA is issuing this guidance document to clarify the subset of 
mobile apps to which the FDA intends to apply its authority. Many 
mobile apps are not medical devices (meaning such mobile apps do not 
meet the definition of a device under section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate 
them. Some mobile apps may meet the definition of a medical device but 
because they pose a lower risk to the public, FDA intends to exercise 
enforcement discretion over these devices (meaning it will not enforce 
requirements under the FD&C Act). The majority of mobile apps on the 
market at this time fit into these two categories.
    Consistent with the FDA's existing oversight approach that 
considers functionality rather than platform, the FDA intends to apply 
its regulatory oversight to only those mobile apps that are medical 
devices and whose functionality could pose a risk to a patient's safety 
if the mobile app were to not function as intended. This subset of 
mobile apps the FDA refers to as mobile medical apps.
    FDA is issuing this guidance to provide clarity and predictability 
for manufacturers of mobile medical apps. Should FDA determine at a 
later date that the policy in this guidance should be changed in light 
of new information, the agency would follow a public process, including 
the opportunity for public input, consistent with FDA's good guidance 
practices (GGP) regulation in 21 CFR 10.115.
    In the Federal Register of July 21, 2011 (76 FR 43689), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by October 19, 2011. FDA reviewed the 
comments and revised the guidance, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 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 email 
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 guidance refers to previously approved information collections 
found in FDA regulations. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction

[[Page 59039]]

Act of 1995 (44 U.S.C. 3501-3520). 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; the 
collections of information in 21 CFR part 814 Subparts B and E are 
approved under OMB control number 0910-0231; and the collections of 
information in 21 CFR part 820 are approved under OMB control number 
0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23293 Filed 9-24-13; 8:45 am]
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