Breakthrough Devices And The Fda Step Program

”Breakthrough Devices” and the FDA SteP Program



As part of the “21st Century Cures Act” in 2017, the FDA introduced a new program for innovative medical devices and combination products designed to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. This program is called the “Breakthrough Device Program,” and it is a voluntary program to facilitate market access by creating a collaborative review process with the FDA with the goal of expedited review.

To be eligible for this program, the medical device or combination product must meet a set of criteria and “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.” However, healthcare innovation goes beyond the treatment or diagnosis of life-threatening or irreversibly debilitating conditions. 

Manufacturers are consistently designing innovative products that improve the safety of current standards of care. These products are not eligible for the Breakthrough Device Program because the underlying conditions are not linked with morbidities and mortalities.

To complement the Breakthrough Device Program, the FDA introduced the “Safer Technologies Program (STeP),” with the final guidance document released in January 2021. Like the Breakthrough Device Program, STeP is an optional program for medical devices and combination products. It is designed to facilitate market access by creating a collaborative review process with the FDA to expedite review. 

STeP is designed for products that are meant to diagnose or treat conditions that are not life-threatening or are considered reasonably reversible and provide an improved safety profile of existing treatments. Medical devices reviewed under STeP will still be required to submit a 510(k) or PMA as applicable.

STeP Benefits

Manufacturers who are early in their medical device design process may want to consider applying for STeP. The program is designed to bring eligible products to market sooner. This is done by earlier engagement with the FDA prior to submitting a 510(k) or PMA. 

STeP is designed to allow manufacturers and the FDA to review data development plans and have more frequent touchpoints during product development. These touchpoints will ultimately lead to a PMA or 510(k) that includes all of the necessary data for the FDA to make a judgment on safety and efficacy. 

Manufacturers who want to utilize STeP should consider engaging with the FDA early in the product’s development to fully utilize this program’s benefits. Once a STeP medical device is submitted via a 510(k) or PMA, manufacturers can expect a prioritized review process.

STeP Eligibility Criteria

Manufacturers who are seeking to participate in STeP must meet both eligibility factors as described below:

Step Criteria chart

Manufacturers who are not eligible for STeP but have questions for the FDA about their medical device can still receive feedback via the FDA’s Q-Submission Process

STeP is an excellent opportunity for manufacturers to engage with the FDA earlier in their product’s development, which will potentially allow for a smoother, faster review period. 

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