In Vitro Diagnostic Devices

The eSubmitter software may be used to submit premarket notification applications, 510(k)s, for In Vitro Diagnostic Devices reviewed at OIVD. Currently, the software supports both “bundled” and single applications for all traditional, abbreviated, and special 510(k)s including:

• Antimicrobial Susceptibility Testing (AST) Devices
• All Other In Vitro Device Types
• CLIA Waiver and Categorization Applications

The Software may also be used to submit 510(k) Supplements. Additional updates are currently under development and will be available on a continuous basis to the users every time the software is launched while connected to the internet.