FDA expands eSTAR filing to de novo devices, IVDs

Regulatory NewsRegulatory News | 02 December 2021 |  By 

US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kicked off in 2020 began with a template for 510(k) device submissions.
Nine companies participated in that pilot program that trialed the interactive, PDF-based filing format. Use of eSTAR was expanded in September 2020 to include all 510(k) filers, except those submitting applications for combination products. In September 2021, FDA issued a draft guidance for how to use the electronic submission template for 510(k) submissions.
“Without changing our statutory or data requirements, this highly interactive submission template is intended to allow manufacturers to provide information to the FDA that’s complementary to CDRH internal review templates,” said CDRH Director Jeff Shuren when the pilot was announced. (RELATED: FDA to pilot interactive 519(k) template, Regulatory Focus 26 February 2020)
Participation in the eSTAR program is voluntary, for now. When the de novo pathway eSTAR template goes live on 3 January 2022 — the same day the final rule for the de novo pathway becomes effective — developers can expect to use templates that incorporate provisions of that rule, according to FDA’s updated eSTAR website. A draft guidance for electronic filing of de novo applications that parallels the 510(k) draft will be forthcoming as well, said the agency.
The eSTAR template allows for standard PDF format features such as autofill; it also guides applicants through each submission section and provides for associated resources such as guidances and databases to be integrated. Developers also receive automatic verification of their filings.
The new Version 1 of eSTAR has been updated with more instructions and some clarifications and includes content that incorporates the provisions of the de novo final rule; however, developers who ae submitting 510(k)s may continue to use older versions of eSTAR if a draft has already been undertaken. New 510(k)s submissions should use eSTAR Version 1.
FDA eSTAR information page


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