FDA To Issue Final Device Post-Market Surveillance Plan In February
This article was originally published in The Gray Sheet
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.
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The agency held a stakeholder meeting to discuss the creation of an international consortium of transcatheter valve registries to serve as the model for future cardiovascular device registry collaborations.
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 latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”