[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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