Breakthrough vs. STeP, which one is more apt for your medical device? – Elexes
Elexes Medical Consulting

Both STeP and Breakthrough Device Program comprises 2 Phases. 

  • In the first Phase, sponsors formally request inclusion in the STeP/Breakthrough Program through a Q-submission 
  • In the second phase, they take actions to expedite the development of the device and review subsequent regulatory submissions


STeP Criteria for Eligibility

  • The device should not be eligible for the Breakthrough Devices Program 
  • The benefit-risk profile of a treatment or diagnosis should be reasonably expected to be significantly improved with the device; like: 

a. A reduction in the occurrence of a known serious adverse event

c. A reduction in the occurrence of a known use-related hazard or use error

b. A reduction in the occurrence of a known device failure mode

d. An improvement in the safety of another device or intervention

Breakthrough Device Designation Criteria for Eligibility

  • The device should provide more effective treatment or diagnosis
  • The device should be intended for a condition or disease that is “life-threatening” or “irreversibly debilitating” 
  • The device’s availability should be in the best interest of the patients for whom it’s intended
  • The device shall offer significant advantages over existing approved or cleared alternatives
  • There should be no approved or cleared alternatives to the device
  • The device shall represent a breakthrough technology

Not all the aforementioned criteria are mandatory, but it is important to know which criteria you should claim for, depending on what data you have for your device.


As resources permit, FDA intends to offer interactive reviews, timely communications, early engagement on Data Development Plans (DDPs), sprint discussions, and senior management engagement.

Breakthrough Device Designation

This program allows numerous interactive reviews and sprint discussions between the Manufacturer who obtains a Breakthrough Designation and the FDA.

Given that there may be novel scientific aspects of devices in STeP and Breakthrough Programs, FDA interacts with External Experts or seeks advice from an advisory committee to reach various regulatory decisions.

Medicare is starting a new coverage pathway for breakthrough devices, Medicare Coverage of Innovative Technology (MCIT). This pathway is intended to accelerate the coverage of new, innovative breakthrough devices. This is a major added advantage that companies shall not receive if they qualify under STeP 

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