US FDA and Health Canada Launch eSTAR Pilot

The US FDA and Health Canada are piloting a single eSTAR submission to both agencies. The pilot of nine participants will evaluate the feasibility of using eSTAR. Requests to participate in the pilot are no longer being accepted.

What is eSTAR?

The eSTAR interactive PDF form helps direct applicants through the medical device submission process.

The template features:

• Automation (for example, form construction and autofill)
• Content and structure is:
  • Complementary to Center for Devices and Radiological Health (CDRH) internal review templates
  • Harmonized with the document used by the International Medical Devices Regulators Forum (IMDRF)
• Integration of multiple resources (for example, guidances and databases)
• Guided construction for each submission section
• Automatic verification

All medical device submitters for 510(k)s and De Novos may voluntarily use eSTAR to submit to CDRH free of charge.

Preparing a submission using eSTAR

The US FDA and Health Canada will provide select participants with an information package.

The package includes:

• The eSTAR form with both US FDA and Health Canada content enabled
• Submission process information, such as url and mailing address

Emergo by UL will post updates as they become available.