The STeP Program is modeled after the Breakthrough Devices Program in expediting the development, assessment, and review of devices that are deemed eligible by the Agency.

“Consistent with the agency’s statutory mission to protect and promote public health, FDA believes that this ‘Safer Technologies Program’ or ‘STeP’ will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance,” the agency said in a news release.

Devices eligible for STeP should improve on existing treatments’ safety by reducing adverse events, device failures, use-related hazards, or user errors, or by improving the safety of other devices or interventions.

If you are interested in whether your new product is eligible, let’s start the conversation to see if it can benefit from this program!

During the pandemic, FDA has received more than 5,000 EUA device requests, but just over 600 have been authorized.

Despite resource reallocation, performance metrics showed CDRH’s Office of Orthopedic Devices hit their 90-day performance goal for 510(k) decision on 100% of applications Accepted in 2020 (qty 636) and 2021 so far (qty 118). Pretty impressive!