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

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

FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway 

The U.S. Food and Drug Administration 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 finalized through guidance earlier this year. The initial device types being considered for eligibility for the Safety and Performance Based Pathway under the draft guidances issued today include...

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