FDA Preps Device Makers To Use eSTAR For De Novo Requests
Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.
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The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.
The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.
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.