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FDA CDRH Portal Now Offers Tracking of Pre-Submissions



On May 22, the FDA announced that it has updated the CDRH Portal to allow users to track the progress of Pre-Submissions. A submitter must specify the type of Pre-Submission request, which include:

  • written feedback (only)
  • written feedback followed by a meeting

The agency noted that the CDRH Portal updates are a step forward in meeting the Medical Device User Fee Amendments 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing industry submissions.

All CDRH-led premarket submission types may be uploaded to the CDRH Portal at any stage of the review process. Official correspondents do not need to send a physical cover letter to the FDA after uploading an electronic submission to the CDRH Portal.

Starting October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR, unless exempted in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the Electronic Submission Template for Medical Device 510(k) Submissions guidance.

Prior to October 1, 2023, companies may submit 510(k)s by mail or through the CDRH Portal in either the eSTAR or eCopy format. De Novo requests submitted using eSTAR remain voluntary until further notice.

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