FDA Takes 'STeP' Forward For Medtech Innovation With Safer Technologies Program Modeled On Agency's Breakthrough Pathway
People with non-life-threatening and reasonably reversible conditions will soon have access to innovative, early development-stage medical devices and device-led combination products thanks to the US FDA's upcoming Safer Technologies Program (STeP). STeP is modeled on, and is a complement to, the agency's popular Breakthrough Devices Program, an accelerated development pathway for devices that the agency finds could provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
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The US FDA released a final guidance document on 5 January that sets in place its new voluntary Safer Technologies Program, or STeP. Modeled after the agency’s burgeoning Breakthrough Devices Program, STeP is for innovative devices and device-led combo products heading for a PMA, 510(k) or de novo regulatory route that aim to treat less serious conditions than devices accepted into the Breakthrough program.
A new final guidance document from the US FDA explains how the agency wants device developers to use its Q-Submission Program to get agency feedback outside the formal product submission process.
US Regulatory Roundup, February 2021: QA/RA Predictions, FDA Warning Letter Stats, PMA Case Study, And More
Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.