FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program

FDA

19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. 

These are anticipated to be the first device types eligible for the new, voluntary premarket notification pathway to market devices, which was first announced in 2018 and finalised through guidance earlier this year.

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Michael Wonder

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Michael Wonder

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US , Regulation , Device