The regulatory lead loads every document into the FDA eSTAR, answers the form questions and clears the template's completeness checks until no required field is open. A final review reads the package as a reviewer would and checks that the indications for use, device name, software version and claims match across all documents. The lead then submits through the CDRH portal as the correspondent after the user fee has cleared.
On the map: Assemble and validate the eSTAR. Final package review. Submit as correspondent.
Rows are disciplines, columns are stages 1 to 8. Select a square to open that task.
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Collect each eSTAR attachment from its owner against a document map. Run one consistency pass across version numbers, device description and labeling before you submit.
Map each controlled document to one eSTAR section before loading anything, and keep the map with the package. A document that answers questions in two sections goes where the reviewer will look first and is cross-referenced from the other.
The applicant is the company that will own the clearance. The correspondent is the person FDA contacts during review, often the regulatory consultant. Settle both, the confidentiality election in the cover letter, and the signer of the truthful and accurate statement before the package is frozen.
Run a final read against a checklist built from the eSTAR and the software and cybersecurity guidances. Confirm the indications for use are identical everywhere, the tested software version matches the described version, and every open Pre-Submission question is answered in the package.
Pay at least three business days before submission so the payment clears and the file is not placed on user fee hold. Fees usually rise on October 1, so a submission near that date is paid early.
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