'Quik' Review Program Builds On US FDA eSubmission Efforts
The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.
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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.
Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.
The US agency issued a proposed rule this week to remove requirements for multiple copies of pre-market submissions, requiring one electronic version instead.