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