Electronic Submission Template and Resource (eSTAR)

How Does Adaptiv Risk Support eSTAR?

The FDA eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR is free and is required for all medical device 510(k) submissions, unless exempted. While eSTAR encompasses the entire regulatory submission, a section of eSTAR is geared towards cybersecurity. Adaptiv Risk was built to specifically support eSTAR filings by capturing and reporting on the cybersecurity details that eSTAR requires. So, when you are ready to file your device, meeting the cybersecurity requirements is as simple as clicking a button. The following table shows the eSTAR section and how Adaptiv Risk supports the requirement.

• Architecture Views: Adaptiv Risk provides an interactive architecture diagram designer.
• Assessment of Unresolved Anomalies: Adaptiv Risk can capture, review and transfer anomaly data.
• Cybersecurity Controls: Adaptiv Risk can ingest controls and create traceability links.
• Cybersecurity Labeling: Adaptiv Risk supports labeling requirements.
• Cybersecurity Management Plan: Adaptiv Risk captures the details documenting how cybersecurity management will occur.
• Cybersecurity Metrics: Adaptiv Risk captures vulnerability lifecycle management metrics.
• Cybersecurity Risk Assessment: Adaptiv Risk supports multiple vulnerability risk assessment methodologies.
• Cybersecurity Testing: Adaptiv Risk can capture and store test reports.
• Risks: Adaptiv Risk is a risk management platform.
• Software Bill of Materials: Adaptiv Risk fully supports CycloneDX.
• Threat Model: Adaptiv Risk provides an interactive threat model designer.

*Some 510(K) submissions are exempt.