Tech group: Proposed changes to 510(k) program "are not needed"

10/5/2010 | Wall Street Journal, The

Introducing extensive changes to the FDA's 510(k) process for clearing medical devices appears to be unnecessary because it could only stall product approval, bring more confusion and "prevent needed technologies from reaching patients," the Advanced Medical Technology Association said as part of a 107-page report. The industry group's statement comes as the agency concluded the comment period for its proposed changes to the 510(k) program.

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