FDA Publishes Guidance on Oct. 1 eStar Requirement

In a final guidance published by CBER and CDRH, the FDA provides updated standards for premarket notification (510(k)) submissions by electronic format and establishes Oct. 1 as the start date for use of the revised standard.

The guidance is part of the FDA’s commitment to the development of electronic submission templates with the goal of improving submission consistency with sponsors using the template as a guided submission preparation tool.

The 16-page guidance, “Electronic Submission Template for Medical Device 510(k) Submissions,” also provides criteria for waivers of and exemptions from the requirements to meet a statutory requirement.

Read the guidance here.

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