FDA Seeking Medical Device Database, Drug Safety Data Mining Tool
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The Food and Drug Administration is asking contractors to develop new databases for national and international medical devices, Nextgov reports.
According to John Pulley’s report, the winner of the one-year contract will run several workshops that could lead to a framework for developing the registries.
Responses are due Thursday and the FDA wants the first workshop to occur in September, the report says.
Goals of the project include developing registries and groups of registries for the National Medical Device Postmarket Surveillance System, developing best practices and promoting strategic planning, Pulley reports.
The agency also wants vendors to provide technology for data mining and pattern recognition, with the goal of predicting safety signals for new drug candidates and evaluating safety signals for drugs on the market.
New drug candidates currently have no known safety signals, Pulley reports.
The FDA proposed a new identification process in July for medical devices, which would involve a new unique identifier on the device.