[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42101-42103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4852]


Design Considerations and Premarket Submission Recommendations 
for Interoperable Medical Devices; Guidance for Industry and Food and 
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 42102]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Design Considerations and 
Pre-market Submission Recommendations for Interoperable Medical 
Devices.'' FDA is issuing this guidance to assist industry and FDA 
staff in identifying specific considerations related to the ability of 
electronic medical devices to safely and effectively exchange and use 
exchanged information. This document highlights considerations that 
should be included in the development and design of interoperable 
medical devices and provides recommendations for the content of 
premarket submissions and labeling for such devices.

DATES: The announcement of the guidance is published in the Federal 
Register on September 6, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-4852 for ``Design Considerations and Premarket Submission 
Recommendations for Interoperable Medical Devices.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 
a.m. and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    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 guidance document entitled 
``Design Considerations and Premarket Submission Recommendations for 
Interoperable Medical Devices'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, 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.

FOR FURTHER INFORMATION CONTACT: Heather Agler, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-796-6340; 
and 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, 301-240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The need and desire to connect medical devices to other products, 
technologies, and systems is growing in the health care community. As 
electronic medical devices are increasingly connected to each other and 
to other technology, the ability of these connected systems to safely 
and effectively exchange information and use the information that has 
been exchanged becomes increasingly important. Advancing the ability of 
medical devices to exchange and use information safely and effectively 
with other medical devices, as well as other technology, offers the 
potential to increase efficiency in patient care.
    FDA intends to promote the development and availability of safe and 
effective interoperable medical devices. FDA is issuing this guidance 
to assist industry and FDA staff in identifying specific considerations 
related to the ability of electronic medical devices to safely and 
effectively exchange information and use exchanged information. This 
document highlights considerations that should be included in the 
development and design of interoperable medical devices and

[[Page 42103]]

provides recommendations for the content of premarket submissions and 
labeling for such devices.
    In the Federal Register of January 26, 2016 (81 FR 4303), FDA 
announced the availability of the draft of this guidance and interested 
persons were invited to comment by March 28, 2016. The comment period 
was extended on February 23, 2016 (81 FR 8966), to April 28, 2016. FDA 
has considered all of the public comments received in finalizing this 
guidance.
    FDA recognizes and anticipates that the Agency and industry may 
need up to 60 days to perform activities to operationalize the policies 
within the guidance. If new information regarding device 
interoperability as outlined in this guidance is not included in a 
premarket submission received by FDA before or up to 60 days after the 
publication of this guidance, CDRH staff does not generally intend to 
request such information during the review of the submission. CDRH 
does, however, intend to review any such information if submitted.

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 
current thinking of FDA on ``Design Considerations and Premarket 
Submission Recommendations for Interoperable Medical Devices.'' It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, subparts A through E, have been 
approved under OMB control number 0910-0231; the collections of 
information in 21 CFR part 814, subpart H have been approved under OMB 
control number 0910-0332; the collections of information in 21 CFR part 
601 have been approved under OMB control number 0910-0338; the 
collections of information in 21 CFR parts 801 and 809 have been 
approved under OMB control number 0910-0485; and the collections of 
information in 21 CFR parts 610 and 660 have been approved under OMB 
control number 0910-0338.

IV. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Design Considerations and Premarket Submission 
Recommendations for Interoperable Medical Devices'' may send an email 
request to <a href="/cdn-cgi/l/email-protection#7d3e392f35503a0814191c131e183d1b191c5315150e531a120b"><span class="__cf_email__" data-cfemail="c78483958fea80b2aea3a6a9a4a287a1a3a6e9afafb4e9a0a8b1">[email protected]</span></a> to receive an electronic copy of 
the document. Please use the document number 1500015 to identify the 
guidance you are requesting.

    Dated: August 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18815 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P


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