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Food and Drug Administration – Electronic Submission Template for Medical Device 510(k) Submissions

This final guidance, which was published in October 2023 provides the standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. The development of electronic submission templates intended to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.

Published on the 6th of november 2023. Read the Catapult’s entire regulatory round-up here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 mai 2024). Food and Drug Administration – Electronic Submission Template for Medical Device 510(k) Submissions. ELSIBI. Consulté le 17 février 2026 à l’adresse https://doi.org/10.58079/11ozs


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