[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Medical Image Communication Devices; Draft Guidance for Industry and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availability of the draft guidance entitled ``Medical Device Data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conform to the proposed policy discussed in this draft guidance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 This draft guidance is not final nor is it in effect at this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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 25, 2014.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requests for a single hard copy of the draft guidance document entitled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
[email protected] 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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