FDA outlines postmarket surveillance plan ahead of public meetings

Fri, 09/07/2012 - 4:40pm
Mass Device

The FDA is gathering feedback on a 4-part plan to strengthen medical device postmarket surveillance ahead of a next week's public workshops and meetings.

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Ahead of a 4-day public meeting blitz, the FDA released a preliminary proposal for strengthening medical device post-market surveillance.

The plan features 4 sections, including the creation of a unique device identifier system and promoting use of national registries.

"Although the United States has a robust postmarket medical device surveillance system, we believe our system can be strengthened by implementing four key changes to our existing program," according to the report. "It bears emphasizing that modernizing medical device postmarket surveillance is a long-term effort. Our proposed strategic changes are intended to complement our existing programs."


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