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The FDA recently issued a docket titled “Strengthening the CDRH’s 510K review process”. They also had a public workshop where industry members were able to provide feedback on challenges with the 510(k) program- specifically issues with predicates, new technologies and scientific evidence, CDRH practices, and PMS. (The docket is attached if anyone is interested.)
I wanted to start a thread to see if any of you have any information about this possible revamp to the 510(k) process. Was anyone able to attend the workshop? I'm curious to hear what everyone thinks!
I wanted to start a thread to see if any of you have any information about this possible revamp to the 510(k) process. Was anyone able to attend the workshop? I'm curious to hear what everyone thinks!
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