Remember a few months back when I wrote about the rumored glucose monitor Apple is working on? One of my comments was that given the amount of time it takes for medical devices to get through the regulatory approval pipeline to not hold your breath.
Well today, the FDA has announced that Apple and some other device companies have worked out a new pilot program that allows them to streamline that process. This seems to me a fairly big deal for a company like Apple who wants to move medical monitoring into consumer devices.
The new program allows the FDA to evaluate a company’s testing protocols and facilities up front and certify them, meaning significant parts of the approval process can be handled as the product is being developed. This will likely shave months or more from the time needed to bring to market a device that will require FDA approval to be sold.
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