Document ID: FDA-2013-N-0001-0127
Agency: fda
Document Type: Notice
Title: American Glaucoma Society/Food and Drug Administration Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery; Public Workshop
Posted Date: 2014-02-03T05:00Z

[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Notices]
[Pages 6203-6204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

American Glaucoma Society/Food and Drug Administration Workshop 
on Supporting Innovation for Safe and Effective Minimally Invasive 
Glaucoma Surgery; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``American Glaucoma Society (AGS)/FDA Workshop 
on Supporting Innovation for Safe and Effective Minimally Invasive 
Glaucoma Surgery.'' This workshop will address the current challenges 
in the assessment of implantable minimally invasive glaucoma surgical 
(MIGS) devices with a focus on clinical trial design and conduct. 
Glaucoma experts will present evidence to better define the appropriate 
patient population, as well as the appropriate evaluation of 
effectiveness and safety for MIGS devices. The primary goal of the 
workshop is to discuss the appropriate clinical trial design and 
conduct for MIGS devices in order to facilitate bringing these 
innovative technologies to the U.S. marketplace.
    Date and Time: The public workshop will be held on February 26, 
2014, from 1 p.m. to 6 p.m. Materials may be picked up starting at 12 
noon.
    Location: The public workshop will be held at the Washington 
Marriott at Metro Center, 775 12th St. NW., Washington, DC 20005.
    Contact: Michelle Tarver, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 2504, Silver Spring, MD 20993, 301-796-5620, FAX: 301-847-8126, 
email: michelle.tarver@fda.hhs.gov.
    Registration: AGS will charge a registration fee to cover its share 
of the expenses associated with the workshop. The registration fee is 
$150 for AGS members and $300 for non-members in advance. Registration 
is available on a first-come, first-served basis. Persons interested in 
attending this public workshop may register online or by telephone. The 
deadline for online registration is February 10, 2014, at 5 p.m. EDT. 
There will be onsite registration on the day of the public workshop 
with the cost of onsite registration being $150 for AGS members and 
$500 for non-members. Early registration is recommended because 
facilities are limited.
    If you need special accommodations due to a disability, please 
contact Ms. Susan Monahan at susan.monahan@fda.hhs.gov or 301-796-5661 
no later than February 3, 2014.
    To register for the public workshop, please visit the AGS Web site 
(http://www.americanglaucomasociety.net/professionals/events/). Those 
interested in attending but unable to access the electronic 
registration site should contact AGS Customer Service to register at 
415-561-8587 or 866-561-8558 (toll free). Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone number. If there are any 
questions with registration, please contact the AGS administrative 
offices at 415-561-8587 or email to the attention of Amber Mendez at 
ags@aao.org. Registrants will receive confirmation after they have been 
accepted. You will be notified if you are on a waiting list.
    Food and beverages will be available for purchase by participants 
during the workshop breaks.
    For more information on the workshop, please see the FDA's Medical 
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.)
    Streaming Webcast of the Public Workshop: This public workshop will 
not be Webcast.
    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 (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
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 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).

SUPPLEMENTARY INFORMATION:

I. Background

    Glaucoma is estimated to be the second leading cause of blindness 
worldwide. Management of this often chronic disease is a challenge for 
both patients and health care providers, requiring the use of multiple 
modalities including drops, lasers, and surgery. In recent years, 
innovative devices have been developed to decrease the risk of glaucoma 
surgery. These MIGS devices have moved the option for surgical 
intervention towards less severe forms of the disease. Hence, the 
appropriate clinical trial design and conduct for the evaluation of the 
safety and effectiveness of MIGS devices has become a topic of debate. 
At this workshop, we will discuss the important clinical trial 
components including subject enrollment criteria, safety parameters, 
and effectiveness endpoints. The workshop seeks to involve industry and 
academia in addressing the challenges in the development of appropriate 
clinical trials to adequately evaluate safety and

[[Page 6204]]

effectiveness for implantable MIGS devices. By bringing together 
relevant stakeholders, we hope to facilitate the improvement of 
regulatory science in this rapidly evolving product area.
    FDA and AGS recognize the unique opportunity this workshop provides 
for all stakeholders of the ophthalmic device community to work 
together to improve trial design for the assessment of new MIGS 
devices, and, thereby, strengthen contributions to improved patient 
care and the protection of the public health.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not 
limited to:
     Definition of MIGS and overview of these procedures;
     defining the patient population for implantable MIGS 
devices;
     determining effectiveness endpoints for implantable MIGS 
devices; and
     determining the appropriate safety parameters for 
implantable MIGS devices.
    These topics will be presented by experts in the associated area, 
and will be discussed by panelists with extensive experience conducting 
glaucoma clinical research.

    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02146 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P