FDA Unveils Plan To Strengthen Device Post-Market Surveillance
This article was originally published in The Gray Sheet
Combining new techniques with improvements to current tools, the strategy aims for "near real-time" post-market surveillance.
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The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.
CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.
The device center plans to publish the final version of its national device post-market surveillance strategy and select a third-party group to run its MDEpiNet public-private partnership by the end of February.