# 3 Systems of Risk for Medical Devices from FDA

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-07
- Length: 39m
- Episode: 194
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda
- Listen: https://podcast.greenlight.guru/episode/3-systems-of-risk-for-medical-devices-from-fda

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer to explain the FDA's three distinct systems for managing medical device risk: product classification (Class I-III), significant vs. nonsignificant risk (SR/NSR) for clinical trials, and software level of concern (Class A-C). Drues argues that these systems are independent yet interdependent, noting that the default Class III status for novel devices often misrepresents actual risk, as seen with the 'Band-Aid' example. He emphasizes that labeling claims can drastically alter a device's classification and risk status, and advises companies to use pre-submissions to align with the FDA before determining SR/NSR status.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=0) Introduction and Overview of FDA Risk Systems
- [2:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=131) Product Classification: Class I, II, and III
- [9:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=588) The Default Class III Problem and De Novo Pathway
- [13:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=835) Labeling Claims and Risk Determination
- [15:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=945) Significant vs. Nonsignificant Risk and IDEs
- [17:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=1060) The Strategic Value of Pre-Submissions
- [23:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=1430) Software Level of Concern: Class A, B, and C
- [32:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda#t=1938) Critique of the Three-System Framework

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- Band-Aid (product)

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- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)

## 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/2021-04-07-3-systems-of-risk-for-medical-devices-from-fda. 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.