CDRH Portal Expanded to Pre-Submission Feedback

FDA has updated its CDRH Portal to allow users to track the progress of pre-submissions. Device premarket submission types may be uploaded to the CDRH Portal at any stage of the review process, according to an agency notice. “Official correspondents do not need to send a physical cover letter to the FDA after uploading an electronic submission to the CDRH Portal,” it says.

For pre-submissions, CDRH says submitters must specify the type of request — either written feedback (only) or written feedback followed by a meeting. The portal update was mandated under last year’s reauthorization of the Medical Device User Fee Amendments 2022 to use technology to enhance efficiency and transparency in reviewing industry submissions. The Center notes that the portal cannot receive submission files larger than 4GB or PDF files with attachments larger than 1GB.