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Notice

Implementation of Post-Approval Studies for Medical Devices; Public Workshop

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Notice Of Public Workshop.

 

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The Food and Drug Administration (FDA) is announcing a public workshop entitled “Implementation of Post-Approval Studies for Medical Devices.” The purpose of the workshop is to facilitate discussion among FDA and other interested parties on issues related to the implementation of Post-Approval Studies for medical devices.

Date and Time: The workshop will be held on June 4, 2009, from 9 a.m. to 5 p.m. and June 5, 2009, from 9 a.m. to 12 p.m. 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., and registration will begin at 8:30 a.m. Please pre-register by May 28, 2009, using the instructions in this document.

Location: The workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993.

Contact Persons: Ellen Pinnow, Center for Devices and Radiological Health (HFZ-541), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-2373, e-mail: ellen.pinnow@fda.hhs.gov; or Daniel Canos, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-2369, daniel.canos@fda.hhs.gov.

Registration: E-mail your name, title, organization affiliation, address, and e-mail contact information to Stephanie Zafonte at SZafonte@s-3.com. There is no fee to attend the workshop, but attendees must register in advance. The registration process will be handled by Social and Scientific Systems, which has extensive experience in planning, executing, and organizing educational meetings. Although the facility is spacious, registration will be on a first-come, first-served basis. 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 Ellen Pinnow (see Contact Persons) at least 7 days before the public workshop.

SUPPLEMENTARY INFORMATION: Back to Top

I. Why Are We Holding This Public Workshop? Back to Top

The purpose of the public workshop is to facilitate discussion among FDA and other interested parties on issues related to the conduct of Post-Approval Studies for medical devices.

II. What Are the Topics We Intend To Address at the Public Workshop? Back to Top

We hope to discuss a large number of issues at the workshop, including, but not limited to:

  • Regulatory requirements for implementing a Post-Approval Study for medical devices;
  • Challenges and successful strategies for the recruitment of participants for Post-Approval Studies;
  • Challenges and successful strategies for the retention and compliance with follow-up requirements of participants for Post-Approval Studies;
  • Using existing infrastructure (e.g., national registries) to facilitate Post-Approval Studies; Using innovative strategies to facilitate Post-Approval Studies;
  • Clinical research organizations, industry, academia, and other clinical trial consultant's perspectives on all of the previous issues related to implementing Post-Approval Studies for medical devices.

III. Where Can I Find Out More About This Public Workshop? Back to Top

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: April 29, 2009.

Daniel G. Schultz,

Director, Center for Devices and Radiological Health.

[FR Doc. E9-10426 Filed 5-5-09; 8:45 am]

BILLING CODE 4160-01-S

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