The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets.
The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the FDA. The agency’s goal is to make a final decision within 60 days of receipt of a 510(k) application for an eligible device.
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The post FDA launches pilot to shorten some 510(k) approval times appeared first on MassDevice.
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