80_FR_10161 80 FR 10124 - Robotically-Assisted Surgical Devices: Challenges and Opportunities; Public Workshop; Request for Comments

80 FR 10124 - Robotically-Assisted Surgical Devices: Challenges and Opportunities; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 37 (February 25, 2015)

Page Range10124-10125
FR Document2015-03769

Federal Register, Volume 80 Issue 37 (Wednesday, February 25, 2015) 
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10124-10125]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03769]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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

10124 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 741–8138 (301–443–0572 in the scheduled open public hearing session, devices. Comments and suggestions Washington, DC area). A notice in the FDA may conduct a lottery to determine generated through this workshop will Federal Register about last minute the speakers for the scheduled open facilitate further development of modifications that impact a previously public hearing session. The contact regulatory science for RAS technologies. announced advisory committee meeting person will notify interested persons Dates and Times: The public cannot always be published quickly regarding their request to speak by workshop will be held on July 27 and enough to provide timely notice. March 2, 2015. July 28, 2015, from 8 a.m. to 5 p.m. Therefore, you should always check the Persons attending FDA’s advisory Location: The public workshop will Agency’s Web site at http:// committee meetings are advised that the be held at FDA’s White Oak Campus, www.fda.gov/AdvisoryCommittees/ Agency is not responsible for providing 10903 New Hampshire Ave., Bldg. 31 default.htm and scroll down to the access to electrical outlets. Conference Center, the Great Room (Rm. appropriate advisory committee meeting FDA welcomes the attendance of the 1503A), Silver Spring, MD 20993. link, or call the advisory committee public at its advisory committee Entrance for the public meeting information line to learn about possible meetings and will make every effort to participants (non-FDA employees) is modifications before coming to the accommodate persons with physical through Building 1 where routine meeting. disabilities or special needs. If you security check procedures will be Agenda: The Pediatric Ethics require special accommodations due to performed. For parking and security Subcommittee of the Pediatric Advisory a disability, please contact Walter information, please refer to http:// Committee will meet to discuss the Ellenberg at least 7 days in advance of www.fda.gov/AboutFDA/ general topic of how procedural the meeting. WorkingatFDA/BuildingsandFacilities/ sedation for nontherapeutic (research) FDA is committed to the orderly WhiteOakCampusInformation/ interventions or procedures in the conduct of its advisory committee ucm241740.htm. pediatric population should be meetings. Please visit our Web site at Contact Person: Mark Trumbore, considered under the Additional http://www.fda.gov/ Center for Devices and Radiological Safeguards for Children in Clinical AdvisoryCommittees/ Health, Food and Drug Administration, Investigations at 21 CFR 50 subpart D. AboutAdvisoryCommittees/ 10903 New Hampshire Ave., Bldg. 66, A brief summary of the subcommittee’s ucm111462.htm for procedures on Rm. 5402, Silver Spring, MD 20993, discussion will then be presented to the public conduct during advisory 301–796–5436, Mark.Trumbore@ FDA Pediatric Advisory Committee on committee meetings. fda.hhs.gov. Tuesday, March 24, 2015. Notice of this meeting is given under FDA intends to make background Registration: Registration is free and the Federal Advisory Committee Act (5 available on a first-come, first-served material available to the public no later U.S.C. app. 2). than 2 business days before the meeting. basis. Persons interested in attending If FDA is unable to post the background Dated: February 20, 2015. this public workshop must register material on its Web site prior to the Leslie Kux, online by July 17, 2015, at 4 p.m. Early meeting, the background material will Associate Commissioner for Policy. registration is recommended because be made publicly available at the facilities are limited and, therefore, FDA [FR Doc. 2015–03900 Filed 2–24–15; 8:45 am] location of the advisory committee may limit the number of participants BILLING CODE 4164–01–P meeting, and the background material from each organization. If time and will be posted on FDA’s Web site after space permits, onsite registration on the the meeting. Background material is DEPARTMENT OF HEALTH AND day of the meeting/public workshop available at http://www.fda.gov/ HUMAN SERVICES will be provided beginning at 7 a.m. AdvisoryCommittees/Calendar/ If you need special accommodations default.htm. Scroll down to the Food and Drug Administration due to a disability, please contact Susan appropriate advisory committee meeting Monahan, Center for Devices and [Docket No. FDA–2015–N–0303] Radiological Health, Food and Drug link. Procedure: Interested persons may Administration, 10903 New Hampshire Robotically-Assisted Surgical Devices: present data, information, or views, Ave., Bldg. 66, Rm. 4321, Silver Spring, Challenges and Opportunities; Public orally or in writing, on issues pending MD 20993–0002, 301–796–5661, email: Workshop; Request for Comments before the committee. Written susan.monahan@fda.hhs.gov no later submissions may be made to the contact AGENCY: Food and Drug Administration, than July 14, 2015. person on or before March 9, 2014. Oral HHS. To register for the public workshop, presentations from the public will be ACTION: Notice of public workshop; please visit FDA’s Medical Devices scheduled between 11:30 a.m. and 12:30 request for comments. News & Events—Workshops & p.m. on March 23, 2015. Those Conferences calendar at http:// individuals interested in making formal The Food and Drug Administration www.fda.gov/MedicalDevices/ oral presentations should notify the (FDA) is announcing the public NewsEvents/WorkshopsConferences/ contact person and submit a brief workshop entitled ‘‘Robotically-Assisted default.htm. (Select this meeting/public statement of the general nature of the Surgical (RAS) Devices: Challenges and workshop from the posted events list.) evidence or arguments they wish to Opportunities.’’ FDA is holding this Please provide complete contact present, the names and addresses of public workshop to obtain information information for each attendee, including asabaliauskas on DSK5VPTVN1PROD with NOTICES proposed participants, and an on the current challenges and name, title, affiliation, address, email, indication of the approximate time opportunities related to robotically- and telephone number. Those without requested to make their presentation on assisted surgical medical devices, which Internet access should contact Mark or before February 26, 2015. Time are classified as Class II medical Trumbore to register (see Contact allotted for each presentation may be devices. The purpose of this workshop Person). Registrants will receive limited. If the number of registrants is to obtain public feedback on confirmation after they have been requesting to speak is greater than can scientific, clinical, and regulatory accepted. You will be notified if you are be reasonably accommodated during the considerations associated with RAS on a waiting list. VerDate Sep<11>2014 18:05 Feb 24, 2015 Jkt 235001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10125 Streaming Webcast of the Public Rockville, MD 20857. A link to the 3. Unique benefits of RAS devices Workshop: This public workshop will transcripts will also be available versus traditional surgical procedures. also be Webcast. Persons interested in approximately 45 days after the public 4. Scientific and technical viewing the Webcast must register workshop on the Internet at http:// considerations for third-party online by Friday, July 17, 2015. Early www.fda.gov/MedicalDevices/ manufacturers seeking to claim that registration is recommended because NewsEvents/WorkshopsConferences/ their surgical instruments can be used Webcast connections are limited. default.htm. (Select this public with legally marketed RAS devices. Organizations are requested to register workshop from the posted events list). 5. Design, administration, and all participants, but to view using one SUPPLEMENTARY INFORMATION: certification of training programs and connection per location. Webcast FDA’s role in this process. participants will be sent technical I. Background 6. The future landscape of RAS and system requirements after registration RAS devices, also known as robotic surgery devices. and will be sent connection access computer-assisted surgical devices, are 7. Considerations regarding information after July 20, 2015. If you used by trained physicians in an appropriate selection of preclinical have never attended a Connect Pro operating room environment for (bench and animal) test methods and event before, test your connection at laparoscopic surgical procedures in patient-centered outcome metrics in https://collaboration.fda.gov/common/ general surgery, cardiac, colorectal, clinical use for different stages of device help/en/support/meeting_test.htm. To gynecologic, head and neck, thoracic, development. get a quick overview of the Connect Pro and urologic surgical procedures. These These topics will be presented by program, visit http://www.adobe.com/ medical devices enable the surgeon to experts in the associated area, followed go/connectpro_overview. (FDA has use computer, software, and robotic by more in-depth discussions and Q&A verified the Web site addresses in this technologies to control and move from all participants. document, but FDA is not responsible surgical instruments through the mouth Dated: February 19, 2015. for any subsequent changes to the Web or through one or more small incisions Leslie Kux, sites after this document publishes in in the patient’s body for a variety of Associate Commissioner for Policy. the Federal Register.) surgical procedures. Some common Comments: FDA is holding this public [FR Doc. 2015–03769 Filed 2–24–15; 8:45 am] procedures that may involve RAS workshop to obtain information on the BILLING CODE 4164–01–P devices include gallbladder, uterus, or specific topics outlined in section II. In prostate removal. order to permit the widest possible opportunity to obtain public comment, As discussed further in section II, DEPARTMENT OF HEALTH AND FDA is soliciting either electronic or there are several clinical and scientific HUMAN SERVICES written comment on all aspects of the challenges associated with regulation of public workshop topics. The deadline RAS devices, such as appropriate Food and Drug Administration for submitting comments related to this nonclinical and clinical evaluation of [Docket No. FDA–2012–N–0359] public workshop is August 26, 2015. RAS devices, use of third-party surgical Regardless of attendance at the public instruments with legally marketed RAS National Medical Device Postmarket workshop, interested persons may devices, and clinical training programs. Surveillance System Planning Board submit either electronic comments to This workshop seeks to involve industry Report; Availability, Web Site Location http://www.regulations.gov or written and academia in addressing these and Request for Comments comments to the Division of Dockets challenges in the development of RAS devices to ensure that there is a AGENCY: Food and Drug Administration, Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. reasonable assurance of safety and HHS. 1061, Rockville, MD 20852. It is only effectiveness for RAS devices while ACTION: Notice; request for comments. necessary to send one set of comments. promoting innovation in a rapidly- developing field. By bringing together SUMMARY: The Food and Drug Please identify comment with the relevant stakeholders including Administration (FDA) is announcing the docket number found in brackets in the scientists, patient advocates, clinicians, availability of the report and Web site heading of this document. In addition, researchers, industry representatives, location where the Agency has posted when responding to specific topics as and regulators, we hope to facilitate the the report entitled ‘‘Strengthening outlined in section II, please identify the improvement of this evolving product Patient Care: Building an Effective topic(s) you are addressing. Received area. National Medical Device Surveillance comments may be seen in the Division System,’’ developed by the National of Dockets Management between 9 a.m. II. Topics for Discussion at the Public Medical Device Postmarket Surveillance and 4 p.m., Monday through Friday, and Workshop System Planning Board. In addition, will be posted to the docket at http:// Topics to be discussed at the public FDA has established a docket where www.regulations.gov. Transcripts: Please be advised that as workshop include, but are not limited stakeholders may provide comments. soon as a transcript is available, it will to, the following: DATES: Submit either electronic or be accessible at http:// 1. The current landscape of RAS written comments by April 27, 2015. www.regulations.gov. It may be viewed devices and the respective Offices, ADDRESSES: Submit electronic at the Division of Dockets Management Divisions, and Branches within FDA comments on this document to http:// asabaliauskas on DSK5VPTVN1PROD with NOTICES (see Comments). A transcript will also involved in the review of pre- and www.regulations.gov. Submit written be available in either hardcopy or on postmarket data associated with these comments to the Division of Dockets CD–ROM, after submission of a devices. Management (HFA–305), Food and Drug Freedom of Information request. Written 2. Challenges, needs, and benefit/risk Administration, 5630 Fishers Lane, rm. requests are to be sent to the Division profiles for indications in various 1061, Rockville, MD 20852. Identify of Freedom of Information (ELEM– surgical areas; e.g. cardio/thoracic, comments with the docket number 1029), Food and Drug Administration, gynecological, otolaryngological, found in brackets in the heading of this 12420 Parklawn Dr., Element Bldg., urological, general. document. VerDate Sep<11>2014 18:05 Feb 24, 2015 Jkt 235001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1


Document Created: 2015-12-18 13:09:10
Document Modified: 2015-12-18 13:09:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop; request for comments.
FR Citation80 FR 10124 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR