FDA – Electronic Submission Template for Medical Device 510 (k) Submissions Guidance for Industry and Food and Drug Administration Staff (Gene and Cell Catapult Regulatory Round-up – September 2022)
The announcement of the guidance was published in the Federal Register on September 22, 2022.
This guidance provides further standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for the establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also intended to represent one of several steps in meeting the FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
See all of the Gene and Cell Catapult’s regulatory round-up for september 2022 here. Published on the 4th of October 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (30 novembre 2022). FDA – Electronic Submission Template for Medical Device 510 (k) Submissions Guidance for Industry and Food and Drug Administration Staff (Gene and Cell Catapult Regulatory Round-up – September 2022). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/o65m
