The federal Food and Drug Administration is becoming stricter about its process for approving medical devices, according to a consultant for regulatory affairs. Those changes are coming about in response to scrutiny and criticism over a process that allows devices to be approved based on their similarity to devices already on the market.
A recent article in the Electronic Engineering Times quotes consultant Chris Henza, who spoke at the DesignMed professional conference in California.
Henza said the 510(k) process, which employs the ...
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