Statement from FDA for Devices and Radiological Health, on FDA’s updates to Medical Device Safety A
date:Nov 21, 2018
ginal surgical repair.

Next week, well announce additional actions aimed at fundamentally modernizing the process for medical device review, particularly as it relates to the 510(k) process.

At the heart of the new actions that were taking today, were announcing that were setting an important and ambitious new goal when it comes to device safety: Ensuring that the FDA is consistently first among the worlds regulatory agencies to identify and act upon safety signals related to medical devices.

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