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Regulatory News In Brief

Hamburg touts FDA device review performance in closed-door Minneapolis meet-up last week with senators and industry. Other regulatory news items include a final rule on memoranda of understanding and a new panel meeting scheduled for Hologic’s first-in-class 3D mammography system.

FDA Commissioner Margaret Hamburg met privately with Minnesota Senate Democrats Al Franken and Amy Klobuchar, along with several device industry representatives in Minneapolis Aug. 22, touting improvements in the agency’s review performance. Hamburg came to the meeting armed with recent FDA statistics pointing to progress in reduced review times and backlogs.

According to slides provided by an agency spokeswoman, as of July, CDRH’s backlog for certain PMAs and decisions for 510(k)s pending for more than 90 days are both...

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