[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10124-10125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0303]
Robotically-Assisted Surgical Devices: Challenges and
Opportunities; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing the public
workshop entitled ``Robotically-Assisted Surgical (RAS) Devices:
Challenges and Opportunities.'' FDA is holding this public workshop to
obtain information on the current challenges and opportunities related
to robotically-assisted surgical medical devices, which are classified
as Class II medical devices. The purpose of this workshop is to obtain
public feedback on scientific, clinical, and regulatory considerations
associated with RAS devices. Comments and suggestions generated through
this workshop will facilitate further development of regulatory science
for RAS technologies.
Dates and Times: The public workshop will be held on July 27 and
July 28, 2015, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503A), Silver Spring, MD 20993. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Mark Trumbore, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5402, Silver Spring, MD 20993, 301-796-5436,
[email protected].
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by July 17, 2015, at 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the meeting/public workshop will be provided beginning at 7 a.m.
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. 66, Rm. 4321,
Silver Spring, MD 20993-0002, 301-796-5661, email:
[email protected] no later than July 14, 2015.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. Those without Internet access should contact Mark Trumbore to
register (see Contact Person). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
[[Page 10125]]
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by Friday, July 17, 2015. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after July 20, 2015. 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 http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in
this document, but FDA is not responsible for any subsequent changes to
the Web sites after this document publishes in the Federal Register.)
Comments: FDA is holding this public workshop to obtain information
on the specific topics outlined in section II. In order to permit the
widest possible opportunity to obtain public comment, FDA is soliciting
either electronic or written comment on all aspects of the public
workshop topics. The deadline for submitting comments related to this
public workshop is August 26, 2015.
Regardless of attendance at the public workshop, interested persons
may submit either electronic comments to http://www.regulations.gov or
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. Please
identify comment with the docket number found in brackets in the
heading of this document. In addition, when responding to specific
topics as outlined in section II, please identify the topic(s) you are
addressing. 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.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts 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).
SUPPLEMENTARY INFORMATION:
I. Background
RAS devices, also known as computer-assisted surgical devices, are
used by trained physicians in an operating room environment for
laparoscopic surgical procedures in general surgery, cardiac,
colorectal, gynecologic, head and neck, thoracic, and urologic surgical
procedures. These medical devices enable the surgeon to use computer,
software, and robotic technologies to control and move surgical
instruments through the mouth or through one or more small incisions in
the patient's body for a variety of surgical procedures. Some common
procedures that may involve RAS devices include gallbladder, uterus, or
prostate removal.
As discussed further in section II, there are several clinical and
scientific challenges associated with regulation of RAS devices, such
as appropriate nonclinical and clinical evaluation of RAS devices, use
of third-party surgical instruments with legally marketed RAS devices,
and clinical training programs. This workshop seeks to involve industry
and academia in addressing these challenges in the development of RAS
devices to ensure that there is a reasonable assurance of safety and
effectiveness for RAS devices while promoting innovation in a rapidly-
developing field. By bringing together relevant stakeholders including
scientists, patient advocates, clinicians, researchers, industry
representatives, and regulators, we hope to facilitate the improvement
of this evolving product area.
II. Topics for Discussion at the Public Workshop
Topics to be discussed at the public workshop include, but are not
limited to, the following:
1. The current landscape of RAS devices and the respective Offices,
Divisions, and Branches within FDA involved in the review of pre- and
postmarket data associated with these devices.
2. Challenges, needs, and benefit/risk profiles for indications in
various surgical areas; e.g. cardio/thoracic, gynecological,
otolaryngological, urological, general.
3. Unique benefits of RAS devices versus traditional surgical
procedures.
4. Scientific and technical considerations for third-party
manufacturers seeking to claim that their surgical instruments can be
used with legally marketed RAS devices.
5. Design, administration, and certification of training programs
and FDA's role in this process.
6. The future landscape of RAS and robotic surgery devices.
7. Considerations regarding appropriate selection of preclinical
(bench and animal) test methods and patient-centered outcome metrics in
clinical use for different stages of device development.
These topics will be presented by experts in the associated area,
followed by more in-depth discussions and Q&A from all participants.
Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03769 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P