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New year, new resolve: CDRH Postmarket Management Group begins work.

Last month, the newly created postmarket transformation management group began its job of changing the way FDA's device center handles safety issues.

Headed by Don St. Pierre, formerly a deputy director in CDRH's Office of In Vitro Diagnostics, the three-person group will implement the recommendations in the November "Report of the Postmarket Transformation Leadership Team: Strengthening FDA's Postmarket Program for Medical Devices"

The new group was formed by CDRH Director Dan Schultz in early December. Serving with St. Pierre, whose new title is associate director for postmarket transformation, are Diane Mitchell, M.D., and Susan Meadows, both of whom helped draft the postmarket recommendations. St. Pierre will report directly to Schultz, and an advisory board including CDRH's seven office directors will provide guidance.

"The major effort will be in changing the way the center conducts business and developing organizational capabilities that will strengthen the postmarket safety of medical devices," St. Pierre told The Gray Sheet.

"This will involve creating cross-office collaborative product groups that combine the scientific, regulatory, and product expertise across the center to address postmarket safety issues, with the goal of early identification of significant device safety issues and rapid intervention to minimize the public health impact," St. Pierre said.

Creation of these collaborative product groups, or "matrix groups," was the top recommendation in the November report.

Although St. Pierre expects CDRH to request extra funding for the postmarket effort, he acknowledged that "we can't count on it and we can't wait." He added: "We plan on simply moving forward with what we have and shifting resources as appropriate."

Alberto Gutierrez, formerly director of the OIVD Division of Chemistry and Toxicology Devices, will replace St. Pierre in the diagnostics office. Jean Cooper, a former division director, replaces Gutierrez.

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Title Annotation:Regulatory Report
Publication:Medical Design Technology
Date:Feb 1, 2007
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