![]() ![]() ![]() ![]() Windows and Mac Users: The most recent validation module versions (for Windows and Mac) were released on November 20, 2020. An updated version to support the new Apple processors is in development. Mac Users: The current validation module for Mac is not compatible with Apple computers that have any variation of the M1/M2 processors. From there, you can send an eCopy to the FDA. The tool guides you through the steps of adding the content and allows you to download a formatted eCopy onto a local drive. The eSubmitter-eCopies Tool page includes a quick reference guide and video tutorials. ![]() The eSubmitter-eCopies Tool creates an eCopy in real time that is consistent with the technical standards described in the eCopy guidance. To prepare an eCopy that meets the technical standards – and to avoid eCopy errors or an eCopy hold – use the resources below to submit and validate your eCopy: eSubmitter-eCopies Tool The technical standards for an eCopy are detailed in Attachment 1 of the eCopy guidance. " For what submission types is an eCopy required?" in the eCopy guidance.įor information about the electronic Submission Template And Resource ( eSTAR), see the Voluntary eSTAR Program web page on FDA.gov. An electronic copy is not considered an electronic submission.įor details on the eCopy program, including the technical standards for eCopies, refer to the eCopy guidance: eCopy Program for Medical Device Submissions (referred to as the eCopy Guidance on this page).Īn eCopy is required for the submission types listed in Section III. Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR.Īn electronic copy (eCopy) is a duplicate device submission in electronic format of the previously required paper copy submission sent to the FDA. OctoThe FDA is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal ("CDRH Portal").īuilding on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online. Send Medical Device eSTAR and eCopy Premarket Submissions Online ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |