Medcrypt developed this 11-question survey to help Medical Device Manufacturers determine whether or not they are prepared for an FDA electronic Submission Template and Resource (eSTAR) Submission.  Note that eSTAR is mandatory for 510(k) submission, optional for de novo (but will be mandatory starting October 1, 2025).  Submission via eSTAR is also voluntary for medical device PMA and Pre-Submissions (a type of Q-Submission) to CDRH.

For the purposes of eSTAR, when you answer the question under "General Device Characteristics" that asks if your device uses software/firmware, if you answer with "Yes," the eSTAR form will propagate sections for software, cybersecurity, and interoperability documentation.  If you answer "No," those sections will remain blank.  In eSTAR, cybersecurity documentation is requested solely on the basis of software/firmware being present in the device.  Note that this is a different bar than is set by Section 524B of the Food, Drug & Cosmetic Act (FD&C), where there are three "and'ed" criteria for a cyber device.  eSTAR expects appropriate cybersecurity documentation for any device containing software even if the device is not a cyber device per statute.

Please check off specific boxes as applicable. Note that a checked box presumes that you can share specific and partial or complete documentation immediately. 

Responses to this checklist will inform a follow-up engagement call where our team of experts can share any insights gathered. 

Please note: This survey and the information included within it do not constitute a regulatory assessment for legal purposes and do not have legal impact on the FDA submission process.