Final Guidance Sets Date For Mandatory De Novo Electronic Submissions

The Food and Drug Administration has published a final guidance document to help sponsors prepare to submit de novo requests electronically. The document, “Electronic Submission Template for Medical Device De Novo Requests,” describes the technical standards associated with preparation of the electronic submission template, or eSTAR, for de novo classification requests solely in electronic format.

“The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary