Not So Fast: FDA Announces End Of QUIK 510(k) Pilot
The pilot program from the US agency is set to close on 30 May after regulators found the competing eSTAR project offered more advantages.
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Nine device makers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.
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 recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.