[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56650-56652]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22518]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Food and Drug Administration/American Glaucoma Society Workshop
on the Validity, Reliability, and Usability of Glaucoma Imaging Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
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public workshop entitled ``FDA/American Glaucoma Society (AGS) Workshop
on the Validity, Reliability, and Usability of Glaucoma Imaging
Devices.'' FDA is co-sponsoring the workshop together with the AGS, a
nonprofit organization that supports glaucoma specialists and
scientists through the advancement of education and research. The
purpose of this public workshop is to provide a forum for discussing
the validity, reliability, and usability of glaucoma imaging devices.
The primary topic to be discussed relates to imaging of the posterior
segment of the eye (e.g., retinal nerve fiber layer, optic nerve head,
ganglion cell layer) using Optical Coherence Tomography (OCT, time
domain and spectral domain), with particular emphasis on normative
databases and the diagnostic performance of OCT for therapeutic
glaucoma products (regulatory considerations) and clinical decision
making (clinical practice considerations).
DATES: Date and Time: The public workshop will be held on October 5,
2012, from 8 a.m. until 5 p.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503), 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: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Brad Cunningham, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993. Phone: 301-796-6620, FAX: 301-847-8126,
email: bradley.cunningham@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
$200 for AGS members and $300 for non-AGS members. Registration is
available on a first-come, first-served basis. Persons interested in
attending this public workshop must register online by September 17,
2012. 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 public workshop will be provided beginning at 7:30 a.m. the
morning of the workshop (October 5, 2012). AGS will charge an on-site
registration fee of $400.
If you need special accommodations due to a disability, please
contact Ms. Cindy Garris at Cynthia.Garris@fda.hhs.gov or 301-796-5861,
no later than September 17, 2012.
To register for the public workshop, please visit the AGS Web site
at: https://www.formstack.com/forms/?1237628-fpPvbj6eU2. 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 meeting/public workshop from the posted events list.) Those
interested in attending but unable to access the electronic
registration should fax the PDF form on the AGS Web site (http://www.americanglaucomasociety.net/client_data/files/2012/259_fdaagsworkshopregistrationform.pdf) to 415-561-8531 to register. Please
complete either the online registration form or the PDF form with the
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. Registrants will receive confirmation after
they have been accepted. You will be notified if you are on a waiting
list.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Persons interested in viewing the webcast must
register online by September 17, 2012. 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 October 1, 2012. 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.)
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, Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hard copy 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
Advances in glaucoma diagnostic devices have been rapid, and these
devices are of increasing importance in the diagnosis and clinical
management of glaucoma. Device hardware is often upgraded and
innovative software, such as measurement algorithms, image
registration, and normative databases, is being added to existing
hardware configurations. The optimal endpoints and strategies for
assessing the safety and effectiveness of these new diagnostic tools in
the management of glaucoma are unclear.
While there are several ophthalmic assessments (e.g., imaging,
perimetry, tonometry, etc.) and ocular spaces (e.g., posterior segment,
anterior chamber angle, etc.) relevant to the diagnosis and management
of glaucoma, the primary topic of this workshop is the imaging of the
posterior segment (e.g., retinal nerve fiber layer, optic nerve head,
ganglion cell layer, etc.) with Optical Coherence Tomography (OCT, time
domain and spectral domain).
II. Topics for Discussion at the Public Workshop
Topics to be discussed at the public workshop include, but are not
limited to:
Issues related to the use of OCT technology (time domain
and spectral domain) in the diagnosis and treatment of glaucoma.
Approaches to verify/validate new diagnostic technologies
and their associated claims as well as factors that affect the quality
of their images and measurements.
Normative/reference databases and their impact on the
diagnostic use of OCT devices.
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Dated: September 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22518 Filed 9-12-12; 8:45 am]
BILLING CODE 4160-01-P