# What is the Safer Technologies Program (STeP) and Can Your Device Use It?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-21
- Length: 32m
- Episode: 189
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it
- Listen: https://podcast.greenlight.guru/episode/what-is-the-safer-technologies-program-step-and-can-your-device-use-it

## Summary

Mike Drues, President of Vascular Sciences, explains the FDA's Safer Technologies Program (STeP) to host John Spear of Green Light Guru. Drues clarifies that STeP is a voluntary priority review designation, not a marketing pathway, designed for devices that improve safety rather than efficacy, distinguishing it from the Breakthrough Devices Program (BDP). He details eligibility criteria, such as reducing serious adverse events or user errors, and outlines the application mechanics, including the 60-day decision timeline and the mutual exclusivity of STeP and BDP designations.

## Chapters

- [0:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=21) Introduction: Mike Drues and Vascular Sciences
- [2:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=134) STeP vs. BDP: Safety vs. Efficacy Focus
- [5:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=319) STeP is Not a Pathway to Market
- [8:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=525) Eligibility Criteria and Intervention Scenarios
- [11:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=705) Burden of Proof and Syringe Examples
- [17:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=1052) Application Mechanics and 60-Day Timeline
- [20:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it#t=1221) Regulatory and Non-Regulatory Benefits

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

early-stage companies

## Mentioned

- FDA (other)
- Vascular Sciences (company)
- Green Light Guru (company)
- Breakthrough Devices Program (other)
- 510 K (other)
- PMA (other)
- De Novo (other)
- CMS (other)

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- [117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards) (Let's Combinate)
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## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-21-what-is-the-safer-technologies-program-step-and-can-your-device-use-it. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.