2010-6446. 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.

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, 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: [e-mail]; 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: [e-mail].

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.