FDA NEWS: Electronic Submission Template for Medical Device 510(k) Submissions
Guidance for Industry and Food and Drug Administration Staff Document issued on September 22, 2022.
The draft of this document was issued on September 29, 2021
This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission 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 elements of a ‘complete’ submission, as required by regulation or essential to FDA’s substantive review of the 510(k) submission. 10 This guidance is not intended to specify the user-interface and detailed content of the eSTAR, but instead is limited to establishing the 510(k) electronic format and standards for complying with section 745(A)(b)(3) of the FD&C Act. FDA intends to implement new versions of eSTAR as relevant policies change. FDA also has an ongoing process to collect and consider public comments and stakeholder feedback, which is described on FDA’s website.
Check the document here!