# Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-05-11
- Length: 41m
- Episode: 203
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program
- Listen: https://podcast.greenlight.guru/episode/comparing-fdas-breakthrough-devices-program-safer-technologies-program

## Summary

Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research, explains the differences between the FDA’s Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP). She details how BDP targets life-threatening conditions with potential for improved efficacy, while STeP focuses on safety benefits for less serious conditions. Schmitt highlights the strategic importance of the indication statement in determining eligibility and warns that these designations can raise the FDA's scrutiny bar for clearance.

## Chapters

- [2:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program#t=159) Overview of BDP and STeP Programs
- [6:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program#t=374) Eligibility Criteria and Indication Statements
- [9:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program#t=551) Submission Process and Q-Submissions
- [17:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program#t=1077) FDA Engagement and Review Challenges
- [27:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program#t=1640) Reimbursement and CMS MCIT Status
- [31:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-11-comparing-fdas-breakthrough-devices-program-safer-technologies-program#t=1906) FDA Backlogs and Division Specifics

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- CMS (company)

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## Citing this page

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