Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother
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.
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The pilot program from the US agency is set to close on 30 May after regulators found the competing eSTAR project offered more advantages.