FDA Launches Pilot eCopy Program To Eliminate Mailing CDs, DVDs, Flash Drives
If the pilot works out, sponsors will be allowed to submit premarket applications using a cloud server in addition to mailing paper copies of their documents.
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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.
FDA spells out its acceptance policies for 510(k) and PMA submissions, as well as guidelines for submitting electronic copies of submissions. The guidances all aim to make the device review process more efficient and speedy.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.