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This article was originally published in Clinica
The US FDA has a full plate of initiatives when it comes to innovation, last week announcing plans to expedite approvals for truly innovative devices. Coming after the CDRH’s four-point strategic plan last month, and the recent CDRH and to-come Institute of Medicine (IoM) recommendations under the 510(k) improvement review, the US is putting a lot of focus on device regulation at present.
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