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Familiar Names To Top US FDA's Reorganized Cardiovascular Devices Office

 
• By Elizabeth Orr

Companies that have brought products through US FDA's current cardiac device review office will come across many of the same review managers in the newly forming Office of Cardiovascular Devices, which will also include a few compliance and surveillance officers on the leadership team. The new office will sit within the device center's nascent "total product lifecycle" Office of Product Evaluation and Quality.

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A new cross-functional cardiovascular device office within US FDA will be managed principally by current cardiac device review leaders, along with some current compliance and surveillance officers. Senior FDA staffer Matthew Hillebrenner unveiled the structure and leadership team members of the new cardiac office at the annual CRT conference in Washington, DC, on March 6.

The changes are part of the device center's efforts to stand up the new Office of Product Evaluation and Quality, which will apply the "total product lifecycle" approach for all...

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