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Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother

 
• By Shawn M. Schmitt

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.

Businessman reaching out for stars

Nine medical device manufacturers will be selected soon by the US Food and Drug Administration to try out a new 510(k) submission template that the agency says will make the premarket review process smoother.

The FDA on 26 February announced a voluntary pilot program for its electronic Submission Template And Resource – or eSTAR – template, which addresses goals outlined in a 2016...

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