[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Pages 10124-10125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03769]



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, 
    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: 
susan.monahan@fda.hhs.gov 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).


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 
    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]