Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother
Executive Summary
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.
You may also be interested in...
New FDA Guidance Offers Additional Info On eStar Submissions
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.
FDA eSTAR Update: 51 Submissions, No Manufacturer Complaints
US FDA biomedical engineer Patrick Axtell gave an update on the streamlined 510(k) submission program at MedCon 2021.
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.