[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6996-6998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02573]
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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; Mobile Medical Applications:
Guidances 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 two guidance documents. FDA is issuing ``Medical Device
Data Systems, Medical Image Storage Devices, and Medical Image
Communication Devices'' to inform manufacturers, distributors, and
other entities that the Agency does not intend to enforce compliance
with regulatory requirements for Medical Device Data Systems (MDDS) and
two similar radiology device types due to the low risk they pose to
patients and the importance they play in advancing digital health. FDA
is also issuing an updated version of the guidance document ``Mobile
Medical Applications,'' originally issued on September 25, 2013, that
has been edited to be consistent with the MDDS guidance document.
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: An electronic copy of the guidance document is available for
[[Page 6997]]
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 guidance document entitled
``Medical Device Data Systems, Medical Image Storage Devices, and
Medical Image Communication Devices'' or the updated version of
``Mobile Medical Applications'' 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. Alternatively, you
may submit written requests for single copies of the guidances to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
Submit electronic comments on the guidances 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 on ``Medical Device
Data Systems, Medical Image Storage Devices, and Medical Image
Communication Devices'' with the docket number found in brackets in the
heading of this document. Identify comments on ``Mobile Medical
Applications'' with the docket number FDA-2011-D-0530.
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, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA recognizes that the progression to digital health offers
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
intercommunication is hardware and software that functions to transfer,
store, convert formats, or display medical device data without
modifying the data or controlling the functions or parameters of any
connected medical device.\1\ In the Federal Register of February 15,
2011 (76 FR 8637), FDA issued a final rule defining MDDS devices,
medical image storage devices, and medical image communications
devices, reclassifying them 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 (FD&C Act).
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\1\ MDDS are not intended to be used for active patient
monitoring.
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Since issuance of the February 2011 final rule, FDA has gained
additional experience with these types of technologies and has
determined that these devices pose a low risk to the public. Therefore,
in the documents that are the subject of this notice, FDA provides
guidance on the compliance policy for MDDS devices, medical image
storage devices, and medical image communication devices and makes
conforming changes to the guidance document ``Mobile Medical
Applications.'' FDA issued a notice of availability of the draft
guidances on June 25, 2014 (79 FR 36072).
The guidance document, ``Medical Device Data Systems, Medical Image
Storage Devices, and Medical Image Communication Devices,'' states that
FDA does not intend to enforce compliance with the regulatory
requirements that apply to MDDS devices, medical image storage devices,
and medical image communications devices. Blood Establishment Computer
Software (BECS) and accessories to BECS are not MDDS devices.
Therefore, this guidance does not address the regulation of those
devices, which FDA intends to address in another forum. If you have
questions about BECS or BECS accessories, please contact the Office of
Communication Outreach and Development, CBER at 800-835-4709, 240-402-
7800, or email [email protected].
The September 25, 2013, version of the guidance entitled ``Mobile
Medical Applications'' has been updated to be consistent with the
policy stated in the guidance document ``Medical Device Data Systems,
Medical Image Storage Devices, and Medical Image Communication
Devices.'' The updated version of ``Mobile Medical Applications'' also
incorporates additional examples from FDA's mobile medical
applications' Web site (see http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm).
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 medical device data systems, medical image
storage devices, and medical image communications devices as well as
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 guidances 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 or from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of ``Medical
Device Data Systems, Medical Image Storage Devices, and Medical Image
Communication Devices'' or ``Mobile Medical Applications'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1400001 to
identify the guidance ``Medical Device Data Systems, Medical Image
Storage Devices, and Medical Image Communication Devices'' or document
number 1741 to identify the guidance ``Mobile Medical Applications.''
IV. Paperwork Reduction Act of 1995
The guidance documents ``Medical Device Data Systems, Medical Image
Storage Devices, and Medical Image Communication Devices'' and ``Mobile
Medical Applications'' refer 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 Review Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 and 809 are approved
under OMB control
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number 0910-0485; the collections of information in 21 CFR part 803 are
approved under OMB control numbers 0910-0437 and 0910-0291; 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 subparts B and C are approved under OMB control number 0910-0625;
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 812 are approved under OMB control number
0910-0078; the collections of information in 21 CFR part 814 subparts A
through E are approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 820 are approved under OMB
control number 0910-0073; and the collections of information regarding
section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) are approved under
OMB control number 0910-0705.
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: February 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02573 Filed 2-6-15; 8:45 am]
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