Standards, Not Predicates Emphasized In Finalized Alternative 510(k) Pathway
Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons.
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The US FDA has extended the comment period on proposed changes to the 510(k) process until May 22, giving stakeholders an extra 30 days. The controversial proposal would publicize devices that used older predicates.
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The device industry is still sorting out the implications of US FDA's recent proposals to make what the agency describes as a major update to the 510(k) process. But regulatory experts say the agency's focus on finding an age-based cut-off for 510(k) predicate devices is misguided, and some argue that Congress should need to sign off on any of the floated policies.