In December 2018, FDA announced plans for a new program--the Safer Technologies Program, also known as STeP, and on September 18, 2019, draft guidance for the STeP program was released. The STeP program picks up where the breakthrough devices program left off. While breakthrough devices are required to treat life-threatening or irreversibly debilitating conditions, STeP devices are not. STeP devices are innovative devices that seek to remove some of the device complications or adverse side effects of the currently available devices or treatments for the indication. Like the breakthrough device program, STeP devices will have to meet specific designation criteria, one of which being that it is not eligible for the breakthrough devices program, and the others consist of explanations of ways in which the device improves the benefit-risk profile over existing treatments.
True to its name, much of the designation criteria for the second factor revolves around safety. So, if you’re wondering whether or not you might have a STeP device, ask yourself a few questions: Does my device improve the benefit-risk profile relative to other treatments for this indication without compromising the effectiveness of the treatment and without increasing the potential for other complications or safety events?
Does my device incorporate an innovative technological feature, or is it an innovative use of existing technology?
Do I facilitate the reduction in a known serious adverse event?
Does my device reduce the occurrence of a device failure mode?
Does my device reduce a known hazard related risk or use error?
Does the use of my device improve the safety or adverse event profile of another device? Check your answers- If you have a yes to 1 and 2, and one of 3-6, you may have a STeP eligible device on your hands (or in your IP). Now, you might be wondering what the STeP program affords you. The benefits are strikingly similar to the breakthrough devices program. Namely, STeP allows for more FDA interaction and priority review of submissions to the agency. The FDA interaction comes again in the form of sprint discussions, data development plans, pre-subs with the potential of prioritization, and regular status updates.
The prioritization means that FDA senior management will be involved in your development and review process and that your 510(k), De Novo, or PMA may undergo faster review timelines to clearance or approval. However, as also noted in the breakthrough devices, truly innovative technologies sometimes have longer review times due to new scientific principles, which is why fully utilizing all the benefits of the program is in your best interest. The more you speak with the agency about your innovative medical device, the more they know about it and how it truly improves the standard of care!
So, think you’ve got a STeP eligible (or breakthrough device program eligible) device, learn more by checking out FDA’s webinar on November 6 and reach out to me at isabella@proximaCRO.com.