[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Pages 14170-14171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Medical Device Epidemiology Network: Developing Partnership 
Between the Center for Devices and Radiological Health and Academia; 
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 a public 
workshop entitled ``Medical Device Epidemiology Network (MDEpiNet): 
Developing Partnership Between the Center for Devices and Radiological 
Health and Academia.'' The purpose of the public workshop is to 
facilitate discussion among FDA and academic researchers with expertise 
in epidemiology and health services research on issues related to the 
methodology for studying medical device performance.
    Date and Time: The public workshop will be held on April 30, 2010, 
from 8 a.m. to 5 p.m. Participants are encouraged to arrive early to 
ensure time for parking and security screening before the meeting. 
Security screening will begin at 7 a.m., and registration will begin at 
7:30 a.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus,

[[Page 14171]]

10903 New Hampshire Ave., Silver Spring, MD 20993.
    Contact: Kristen Van Dole, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-6334, email: [email protected]; or 
Mary Beth Ritchey, Center for Devices and Radiological Health (CDRH), 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993, 307-796-6638, email: [email protected].
    Registration: Email your name, title, organization affiliation, 
address, and email contact information to Kristen Van Dole (see 
Contact) by April 19, 2010. There is no fee to attend the public 
workshop, but attendees must register in advance. Registration will be 
on a first-come, first-served basis and we ask that one person per 
institution be selected to represent the entity at the workshop. Non-
U.S. citizens are subject to additional security screening, and they 
should register as soon as possible. If you need special accommodations 
because of a disability, please contact Mary Beth Ritchey (see Contact) 
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 
among FDA and the academic epidemiology and health services research 
community on issues related to the methodology of studies for medical 
device performance.
    We aim to reach out to academic centers that have epidemiologic, 
statistical, and clinically relevant expertise to establish a network 
that will work with FDA experts to determine the evidence gaps and 
questions, datasets and approaches for conducting robust analytic 
studies and improve our understanding of the performance of medical 
devices (including comparative effectiveness studies). The centers 
participating in the network will be expected to take part in other 
FDA-hosted scientific workshops that address methods for medical device 
comparative analyses, best practices and best design and analysis 
methods.

II. Who is the Target Audience for This Public Workshop? Who Should 
Attend This Public Workshop?

    This workshop is open to all interested parties. The target 
audience is comprised of academic researchers with experience in 
epidemiology or health services research with an interest in medical 
device outcome and epidemiologic study methodology.

III. What Are the Topics We Intend to Address at the Public Workshop?

    We intend to discuss a large number of issues at the workshop, 
including, but not limited to:
     Gaps and challenges in medical device outcomes and 
epidemiologic studies;
     Creation of the Medical Device Epidemiology Network 
(MdEpiNet) infrastructure; and
     Opportunities for medical device epidemiologic research 
and partnerships between CDRH and Academia.

IV. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 
http://www.fda.gov/cdrh/meetings.html.

    Dated: March 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6446 Filed 3-23-10; 8:45 am]
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