[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49775-49776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Food and Drug Administration/National Heart, Lung, and Blood 
Institute/National Science Foundation Public Workshop on Computer 
Methods for Medical 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 public 
workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for 
Medical Devices.'' FDA is cosponsoring the conference workshop with the 
National Heart, Lung, and Blood Institute (NHLBI) of the National 
Institutes of Health and the National Science Foundation (NSF). The 
purpose of the workshop is to facilitate discussion between FDA and 
other interested parties on the use of computational modeling in the 
design, development and evaluation of medical devices.
    Dates and Times: The public workshop will be held on September 7, 
8, and 9, 2011, from 9 a.m. to 5 p.m. An optional FDA Microstructure 
Modeling session will be held from 1 to 5 p.m. on September 6, 2011. 
Participants are encouraged to arrive early to ensure time for parking 
and security screening before the meeting. Security screening will 
begin at 8 a.m. Persons interested in attending this public workshop 
must register by 5 p.m. on August 30, 2011.
    Location: The public workshop and optional session will be held at 
the FDA White Oak Campus, 10903 New Hampshire Ave, Building 31 
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002.
    Contact Persons: Donna R. Lochner, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, rm. 3220, Silver Spring, MD 20993-0002, 301-796-6309, 
e-mail: <a href="/cdn-cgi/l/email-protection#51353e3f3f307f3d3e32393f3423113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="d7b3b8b9b9b6f9bbb8b4bfb9b2a597b1b3b6f9bfbfa4f9b0b8a1">[email protected]</span></a>; or
    Tina M. Morrison, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1272, 
Silver Spring, MD 20993-0002, 301-796-6310, e-mail: 
<a href="/cdn-cgi/l/email-protection#afdbc6c1ce81c2c0ddddc6dcc0c1efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="93e7fafdf2bdfefce1e1fae0fcfdd3f5f7f2bdfbfbe0bdf4fce5">[email protected]</span></a>.
    Registration: To register for the public workshop and optional 
session, please visit the following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to 
http://www.fda.gov and select the FDA Medical Devices News & Events--
Workshops & Conferences calendar and select this public workshop from 
the posted events list). Please provide complete contact information 
for each attendee, including name, title, affiliation, address, email, 
and telephone number. For those without Internet access, please call 
the contact person to register. Registration is mandatory as space is 
limited and onsite registration will not be available. FDA may limit 
the number of participants from each organization. There is no 
registration fee for the public workshop.
    Registrants requesting to present written materials or to make oral 
presentations at the public workshop, please call the contact persons 
by August 23, 2011.
    If you need special accommodations because of 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,

[[Page 49776]]

MD 20993-0002, 301-796-5661 at least 7 days before the public workshop.

SUPPLEMENTARY INFORMATION: 

I. Why are we holding this public workshop?

    The purpose of the public workshop is to facilitate discussion 
between FDA and other interested parties on the use of computational 
modeling in medical device design, development and evaluation.

II. What are the topics we intend to address at the public workshop?

    We hope to discuss a large number of issues at the public workshop, 
with our overall theme being the validation of computer models with 
nonclinical models. Topics include, but are not limited to the 
following:
    <bullet> Advancing Computational Modeling Studies--how is 
computational modeling being used for device design, development, and/
or evaluation?
    <bullet> Best Validation Practices--what validation scheme has 
worked for computational model systems?
    <bullet> Lessons Learned--what validation schemes have been 
unsuccessful for computational model systems?
    <bullet> Data Resources--where are data for boundary conditions, 
loading conditions, material properties, etc. obtained for model 
systems?

III. Where can I find out more about this public workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, food services, and 
other relevant information will be posted, as it becomes available, on 
the Internet at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to http://www.fda.gov and 
select the FDA Medical Devices News & Events--Workshops & Conferences 
calendar and select this public workshop from the posted events list).

    Dated August 8, 2011.
Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological 
Health.
[FR Doc. 2011-20446 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P


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