Document ID: FDA-2015-N-0001-0035
Agency: fda
Document Type: Notice
Title: Biomedical Engineering Society and FDA Frontiers in Medical Devices: Innovations in Modeling and Simulation
Posted Date: 2015-04-02T04:00Z

[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17757-17758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07551]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Biomedical Engineering Society and FDA Frontiers in Medical 
Devices: Innovations in Modeling and Simulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Public Conference

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    The Food and Drug Administration (FDA) in co-sponsorship with the

[[Page 17758]]

Biomedical Engineering Society (BMES) is announcing a public conference 
entitled ``Frontiers in Medical Devices: Innovations in Modeling and 
Simulation''. The purpose of this conference is to provide a forum to 
discuss strategies to effectively utilize computational modeling and 
simulation in the development and evaluation of medical devices.
    Date and Time: The conference will be held on May 18 through 20, 
2015, from 8 a.m. to 6 p.m.
    Location: The public conference will be held at the Marriott Inn 
and Conference Center, University of Maryland, 3501 University Blvd. 
East, Hyattsville, MD 20783.
    Contact Person: 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, 301-796-6309, 
Donna.Lochner@fda.hhs.gov.
    Registration: To register for the public conference please visit 
FDA's Medical Devices News, Events, Workshops, and Conferences calendar 
at http://www.bmes.org/meddevicesconference. There is a registration 
fee to attend the public conference to cover the expenses, and 
attendees must register in advance. The fees vary depending upon 
membership status in BMES, and include BMES members ($450), non-BMES 
members (includes 1 year BMES membership) ($600), and Government rate 
(BMES memberships and meals are not included) ($250). Students will be 
offered a discounted fee of $300 (BMES member) or $350 (non-BMES 
member) (includes 1 year BMES membership). A full listing of the 
registration fees can be found on the Web site listed. Although the 
facilities are spacious, registration will be on a first-come, first-
served basis.
    If you need special accommodations due to a disability, please 
contact Betse Lyons at Betse@bmes.org or 301-459-1999, 8201 Corporate 
Drive, Suite 1125, Landover, MD 20785-2224, FAX: 301-459-2444, no later 
than May 4, 2015.
    To register for the public conference, please visit BMES Frontiers 
in Medical Devices registration page at http://bmes.org/meddevicesregistration. Those without Internet access should contact 
Betse Lyons at 301-459-1999 to register.

SUPPLEMENTARY INFORMATION:

I. Background

    The Center for Devices and Radiological Health (CDRH) believes that 
computer modeling and simulation (M&S) has the potential to 
substantially augment traditional models used to evaluate medical 
devices; i.e., animal, bench, and human models, and to accelerate and 
streamline the total product life cycle of a medical device. The use of 
computer models to simulate multiple use conditions and to visualize 
and display complex processes and data can revolutionize the way 
medical outcomes and medical devices are understood. Non-proprietary 
computer models could benchmark device performance, yet lack of access 
to biomedical data to construct the models and rigorous methods to 
validate the models limit their credibility and use. To foster good 
science for M&S in the medical device community, CDRH needs to leverage 
the expertise in industry and academia to advance M&S for regulatory 
uses.

II. Topics for Discussion at the Public Workshop

    A large number of issues will be discussed at the conference with 
the overall theme being the application of modeling and simulation for 
medical devices at different stages in the total product life cycle. 
Topics include, but are not limited to the following:
     Model foundations for device design ideation;
     concept development and design optimization;
     modeling for robust design;
     design verification and validation;
     patient specific design;
     integration of modeling with clinical studies;
     modeling and device commercialization.
    This public workshop may also form the basis for future discussions 
related to computer modeling and simulation that could benefit U.S. 
public health.

    Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07551 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P