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Jeffrey Shuren to Host CDRH Town Hall Meetings BY LAUREN UZDIENSKI, MAY 18, 2010

Today CDRH director Jeffrey Shuren will host a town hall meeting in Bloomington, Minnesota. On the agenda is an overview of the device group's 2010 priorities, but Shuren is also looking to get feedback from the device industry and the public.

The Minnesota date is the first in a town hall series that Shuren told the Minneapolis Star-Tribue would be an "informal", "back-and-forth dialogue" aiming to get at the "issues, concerns [and] topics on the public's mind." Shuren will visit Boston on June 22nd and Los Angeles in October.

ucm195424.pngIn comments to the Star-Tribune, Shuren spoke to potential changes to the 510(k) process, echoing prior statements that any short-term changes would encompass the "no-brainers." More controversial recommendations may come with the IOM report, which should be ready by next summer. Shuren also addressed potential threats to innovation and fundraising difficulties associated with 510(k) reform, topics sure to come up further in the town hall events.

The town halls will not be broadcast or videotaped, but transcripts are expected to be available.

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