[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6188-6190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0235]


Orthopaedic Sensing, Measuring, and Advanced Reporting Technology 
Devices; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Orthopaedic 
Sensing, Measuring, and Advanced Reporting Technology (SMART) 
Devices.'' The purpose of the public workshop is to discuss the 
development of Orthopaedic SMART Devices. The workshop is intended to 
enhance engagement with stakeholders to facilitate device development 
and to discuss scientific and regulatory challenges associated with 
Orthopaedic SMART Devices. Public input and feedback gained through 
this workshop may aid in the efficient development of innovative, safe, 
and effective Orthopaedic SMART Devices for better patient care.

DATES: The public workshop will be held on April 30, 2018, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public workshop by May 29, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver 
Spring, MD 20993. Entrance for the public workshop participants (non-
FDA employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before May 29, 2018. The https://

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www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 29, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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:
     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.
     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-2018-N-0235 for ``Orthopaedic Sensing, Measuring, and Advanced 
Reporting Technology Devices; Public Workshop; Request for Comments.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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 between 9 a.m. 
and 4 p.m., Monday through Friday.
     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.

FOR FURTHER INFORMATION CONTACT: Andrew Baumann, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 62, Rm. 2110, Silver Spring, MD 20993, 301-796-
2508, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is sponsoring a public workshop to discuss the engineering, 
clinical, regulatory, cybersecurity, and real world evidence aspects of 
Orthopaedic SMART Devices. The technologies of interest incorporate 
sensor equipped implants and instruments that generate information 
related to orthopaedic device performance and patient health. FDA 
understands that these technologies will play a role in the future of 
orthopaedics by providing objective data to the appropriate stakeholder 
that may optimize patient care. A public discussion of these topics 
will help the orthopaedic medical device community better understand 
the development of and considerations for these technologies. The 
workshop may help FDA and stakeholders prepare for the submittal and 
review of related applications.

II. Topics for Discussion at the Public Workshop

    The public workshop will consist of presentations and panel 
discussions. Presentations will frame the topic and provide information 
on specific aspects of orthopaedic SMART device technology. Following 
the presentations, moderated discussions will ask speakers and 
additional panelists to provide their individual perspectives. Four 
rounds of presentations and panel discussions will cover the following 
topics:

 Engineering/Technology (morning)

    This session will introduce orthopaedic sensor technologies and 
cover the current state of research and industry adoption. Future 
applications of these technologies will be explored.

 Clinical/Patient perspective (morning)

    This session will cover the importance and potential utility of 
these technologies for clinicians and patients. Considerations for 
adopting these new technologies into existing health care paradigms 
will be discussed.

 Cybersecurity (afternoon)

    This session will cover current cybersecurity issues and 
considerations. An overview of FDA's cybersecurity considerations and 
guidance documents will be presented.

 Regulatory Considerations (afternoon)

    This session will discuss FDA's current and evolving thinking on 
Digital Health, clinical study considerations, including the role of 
real-world evidence, relevant guidance documents, and evidence 
generation related to Orthopaedic SMART Devices.
    A detailed agenda will be posted on the following website in 
advance of the workshop: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm and select this event from the list of 
items provided.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
FDA's Medical

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Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by April 20, 2018, by 4 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when they have been accepted. If 
time and space permit, onsite registration on the day of the public 
workshop will be provided beginning at 7:30 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
[email protected], no later than April 16, 2018.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. The webcast link will be available on the registration 
web page after April 20, 2018. Organizations are requested to register 
all participants, but to view using one connection per location.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available 
approximately 45 days after the public workshop on the internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

    Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02923 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P