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'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover

Executive Summary

CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.

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Day 1: US FDA Launches New 'Super Office,' Says It’s Already Proven Its Worth

Speaking at MedCon 2019, CDRH Director Jeff Shuren announced 1 May is officially the first day for the agency’s new Office of Product Evaluation and Quality. The agency lists several examples of how it has already been used in a pilot setting to remove potentially harmful products from market sooner, and resulted in more efficient and safer product reviews.

FDA Device Center Reorg Set To Roll Out This Week

US FDA's Center for Devices and Radiological Health will finally launch a long-planned reorganization that will see agency staff grouped by device types, rather than by stage in the device-review cycle. The reorganization begins this week and should be complete by Sept. 30.

Mercy, J&J Partner To Evaluate Medical Devices

As US FDA has been on a quest to encourage gathering more real-world data, companies like Medtronic and Johnson & Johnson seem to be hopping on the bandwagon with partnerships to gather and analyze how their products really perform.

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