[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://
[[Page 6189]]
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
[[Page 6190]]
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