[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

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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 ocod@fda.hhs.gov.
    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 CDRH-Guidance@fda.hhs.gov 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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