www.fdanews.com/articles/149584-registries-offer-promise-for-postmarket-monitoring-but-hurdles-remain-experts
Registries Offer Promise for Postmarket Monitoring, But Hurdles Remain: Experts
September 20, 2012
Registries Offer Promise for Postmarket Monitoring, But Hurdles Remain: Experts
Registries that track a device through the entire product lifecycle could offer a wealth of information to stakeholders, but how they should be designed and administered remains problematic, experts say. Key questions that could be answered with postmarket registries include whether a device’s efficacy lives up to the data in premarket trials, the long-term effects of an implanted device and how a device compares to alternative treatments, said Rick Kuntz, chief scientific, clinical and regulatory officer at Medtronic.
Devices & Diagnostics Letter
Registries that track a device through the entire product lifecycle could offer a wealth of information to stakeholders, but how they should be designed and administered remains problematic, experts say. Key questions that could be answered with postmarket registries include whether a device’s efficacy lives up to the data in premarket trials, the long-term effects of an implanted device and how a device compares to alternative treatments, said Rick Kuntz, chief scientific, clinical and regulatory officer at Medtronic.
Devices & Diagnostics Letter