The U.S. Food and Drug Administration (FDA) has announced that it will be holding a public workshop entitled "Implementation of Post-Approval Studies for Medical Devices." The FDA says the workshop's purpose is for discussion of issues related to post-approval studies of medical devices among interested parties.

The workshop is to be held in Silver Spring, MD at the FDA White Oak Campus, on June 4, 2009, from 9 a.m. to 5 p.m. and June 5, 2009, from 9 a.m. to 12 p.m. Anyone interested in registering to attend the workshop should do so by May 28, by e-mailing their name, title, organization affiliation, address, and e-mail contact information to Stephanie Zafonte at SZafonte(at)s-3.com. The workshop does not have a fee but does require advance registration and is first-come, first-serve for space.

According to the FDA's public notice, the agenda intends to include:
--Regulatory requirements on implementation for a Post-Approval Study for medical devices;

--Challenges and successes in strategies for recruiting participants for Post-Approval Studies;

--Challenges and successes in the retention and compliance with follow-up requirements of participants for Post-Approval Studies;

--Using existing infrastructure such as 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 perspectives on all prior issues related to implementing Post-Approval Studies for medical devices.

Information on the FDA's public meetings, including archives, is available at: http://www.fda.gov/cdrh/meetings.html.

Based on a Public Notice by the FDA accessed at the Government Printing Office website.

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