Manatt Health January 15, 2021
On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal of expediting development and FDA review of medical devices or device-led combination products that are likely to offer safer treatment or diagnosis of certain diseases and conditions as compared to currently available alternatives. Such alternatives may include currently marketed medical devices or other standard care practices, such as use of FDA-approved drugs and biologics.
STeP was designed as a complement to the existing Breakthrough Devices Program, another voluntary pathway that aims to accelerate access to treatments and diagnostics offering additional benefits...
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