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www.fdanews.com/articles/123440-experts-industry-could-face-some-tough-times-in-2010

Experts: Industry Could Face Some Tough Times in 2010

January 6, 2010
With the 510(k) process under review and regulatory changes in the works, devicemakers can expect a tough year in 2010 for regulatory approvals, experts say. “Sponsors should expect a more difficult time with the FDA in order to get things to market,” John Smith, a partner at Hogan & Hartson and an FDA device expert, said. The change in processing 510(k)s is just one example of policy changes that are leading to the “creation of a new world order at the agency,” regulatory expert Arthur Rankis said.
Devices & Diagnostics Letter