I am assuming the CORIS application to the FDA is now with the...

I am assuming the CORIS application to the FDA is now with the FDA.

CORIS is a De NOVA application. If approved CORIS will be a benchmark. No predicate exists.

So my attention shifts to the FDA STeP classification.

The SaferTechnologies Program (STeP) stands apart from other FDA programs dueto its specific focus on medical devices that

significantly enhance safety forconditions with less serious morbidities and mortalities.Let’s delve into the differences:

1. Breakthrough Devices Program (BDP) vs. STeP:

• BDP targets devices that address life-threatening or debilitating conditions.
• STeP focuses on devices for conditions with less severe outcomes.
• Both programs aim to expedite access to innovative devices.

Eligibility:

• BDP: Eligible for devices that provide substantial clinical benefit.
• STeP: Eligible for devices that enhance safety without meeting BDP criteria.

Benefits:

• BDP: Intensive FDA interaction, priority review, and expedited access.
• STeP: Collaborative interactions, timely feedback, and early engagement.