[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Page 36072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14769]



[[Page 36072]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0798]


Medical Device Data Systems, Medical Image Storage Devices, and 
Medical Image Communication Devices; Draft Guidance for Industry and 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availability of the draft guidance entitled ``Medical Device Data 
Systems, Medical Image Storage Devices, and Medical Image Communication 
Devices.'' FDA is issuing this document to inform manufacturers, 
distributors, and other entities that the Agency does not intend to 
enforce compliance with the regulatory controls that apply to Medical 
Device Data Systems (MDDS), medical image storage devices, and medical 
image communications devices, due to the low risk they pose to patients 
and the importance they play in advancing digital health. In this 
document, FDA is also proposing changes to its guidance entitled 
``Mobile Medical Applications,'' issued on September 25, 2013, to 
conform to the proposed policy discussed in this draft guidance 
document. This draft guidance is not final nor is it in effect at this 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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 25, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Medical Device Data Systems, Medical Image Storage Devices, and 
Medical Image Communication Devices'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5431, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.
    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: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA recognizes that the progression to digital health offers the 
potential for better, more efficient patient care and improved health 
outcomes. To achieve this goal requires that many medical devices be 
interoperable with various types of health information technology, 
including other types of medical devices. The foundation for such 
inter-communication is hardware and software that transfer, store, 
convert formats, and display medical device data. FDA has called such 
technologies MDDS. A MDDS does not modify the data, and it does not 
control the functions or parameters of any connected medical device. 
MDDS are not intended to be used for active patient monitoring.
    On February 15, 2011 (76 FR 8637), FDA issued a regulation down-
classifying MDDS from class III (high-risk) to class I (low-risk). 
Class I devices are subject to general controls under the Federal Food, 
Drug, and Cosmetic Act. Since then, FDA has gained additional 
experience with these types of technologies and has determined that 
these devices pose a low risk to the public. Therefore, this document 
proposes a compliance policy whereby FDA would not intend to enforce 
compliance with the regulatory controls that apply to MDDS devices, 
medical image storage devices, and medical image communications 
devices.
    This document also proposes changes to the Agency's 2013 guidance 
entitled ``Mobile Medical Applications'' which would conform to the 
policy stated in this document, once this document is finalized. Upon 
finalization, the description of these conforming changes will be 
removed from this document and FDA will issue an updated version of the 
``Mobile Medical Applications'' guidance that incorporates these 
changes.

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 medical 
device data systems, medical image storage devices, and medical image 
communications devices. 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 downloading an electronic copy from 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. Persons unable to download an electronic 
copy of ``Medical Device Data Systems, Medical Image Storage Devices, 
and Medical Image Communication Devices'' may send an email request to 
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document. Please use the document number 1400021 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

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: June 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14769 Filed 6-24-14; 8:45 am]
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