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Design
Editorial
Highlights the importance of FDA initiatives to improve postmarketing surveillance and safety monitoring of implantable medical devices.
Interview with Sharon-Lise Normand on medical device approval and postmarketing surveillance. (00:00)Download Failures of implantable medical devices can carry substantial risk of serious injury, and effective systems for monitoring safety after marketing begins are essential. Several FDA initiatives have been launched to fill the gaps in the passive event-reporting system.
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Resnic et al. (2012) studied this question.
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