[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Pages 56650-56652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22518]



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.


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 
    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.)


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]