The Safer Technologies Program (STeP) for Medical Devices is a novel, voluntary program established by the FDA to expedite the entry of medical devices into the US market by emphasizing improvements in safety over efficacy. The Global Medical Device Podcast, hosted by Jon Speer and featuring Mike Drues from Vascular Sciences, offers comprehensive insights into how STeP compares to the Breakthrough Devices Program (BDP) and lays out the eligibility criteria for devices under STeP.
STeP aims to enhance medical devices and combination devices that are also within the scope of the BDP but focuses on enhancing safety rather than efficacy. Devices that exhibit safety improvements, as well as efficacy, must choose between STeP and BDP since they are mutually exclusive and function as complements rather than alternatives to regulatory pathways such as the 510(k) or the De Novo process. The criteria for STeP eligibility includes evidence of increased benefit/risk ratio, reduced device failure modes, and a decrease in user-related errors, among other safety improvements.
Unlike BDP, which prioritizes life-threatening or significantly debilitating conditions, STeP is intended for devices addressing less severe conditions. Applying for either STeP or BDP follows a similar process which includes assembling a pre-submission meeting strictly focused on demonstrating whether the device meets the specific criteria for STeP or BDP, without blending this process with a traditional pre-submission.
Devices that receive STeP or BDP designation are given priority treatment by the FDA, though this does not mean a reduction in regulatory burden—manufacturers must still meet all standard requirements for testing and approval. Importantly, the distinctions between STeP and BDP hinge on the kind of improvement (safety vs. efficacy) and severity of the condition being targeted.
In one detailed example, Mike Drues explained how a new type of syringe designed to minimize needle stick injuries could potentially qualify for STeP because it improves safety but not efficacy. Different scenarios were elucidated where a device either singularly improves safety or does so in a supporting role with other devices during medical interventions.
As the STeP program revives after being overshadowed by the focus on the COVID-19 pandemic, its potential to incentivize manufacturers to improve the safety of medical devices is becoming clearer. The discussion also highlighted non-regulatory benefits such as potentially favorable reimbursement scenarios or enhancing credibility with investors.
Listeners were encouraged to consider STeP for devices that significantly enhance safety while meeting the program’s specific conditions, particularly if these improvements do not also entail treating severe and debilitating diseases—a domain reserved for BDP.
This episode serves as an essential resource for medical device manufacturers aiming to understand FDA’s new STeP initiative, its distinctions from similar programs, and the strategic implications of opting for this approach to market entry and device development.
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