FDA Unveils Plan To Strengthen Device Post-Market Surveillance

Article preview from "The Gray Sheet"-  September 10, 2012

Combining new techniques with improvements to current tools, the strategy aims for "near real-time" post-market surveillance.

 FDA Unveils Plan To Strengthen Device Post-Market Surveillance

Article preview from "The Gray Sheet"-  September 10, 2012

FDA issued a white paper Sept. 6 with a four-part approach to strengthening its medical device post-market surveillance system, blending new strategies with already-planned improvements to existing tools.

FDA says its vision is to create a post-market system that can "quickly identify poorly performing devices" and "accurately characterize and disseminate information about real-world device performance, including the clinical benefits and risks of marketed devices."

The plan is the result of an Institute of Medicine recommendation – one of many in IOM's July 2011 report on the 510(k) device clearance program – that FDA develop and implement a comprehensive strategy to collect, analyze and act on medical device post-market performance.

The plan encompasses several device center initiatives that are currently underway, including establishing a unique device identifier system – which was introduced in a proposed rule in July – and promoting its incorporation into electronic health records. It also promotes the continued development of national and international registries in selected product areas "of high importance."

The strategy also focuses on automating some aspects of adverse event reporting and analysis, a technique being piloted at selected hospitals through the ASTER-D (Adverse Spontaneous Triggered Events Reporting for Devices) program.