Industry, FDA Coming Together On Risk Management For Marketed Devices
This article was originally published in The Gray Sheet
Representatives from the device industry and FDA are trying to establish common ground for how to assess and manage risk of potential safety or compliance issues that crop up for marketed devices.
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FDA has already put a lot of work into mapping out pathways for weighing benefit versus risk in premarket review decisions. Now the agency, with the help of the Association for the Advancement of Medical Instrumentation and industry, is trying to provide the same support for compliance and enforcement decisions.
The most popular "Gray Sheet" stories in 2015 dug deep into regulatory developments and concepts, and provided guidance on how to respond. Quality control topics and analysis of FDA's premarket review processes dominates the list.
FDA says it will hold an interactive workshop on April 21 to discuss the "clinical considerations of risk in the postmarket environment." The meeting will build on a process launched last fall when representatives from industry and FDA met to establish draft principles for managing unanticipated risks for marketed devices.