# Understanding the Investigational Device Exemption (IDE) Process

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-03-31
- Length: 57m
- Episode: 192
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process
- Listen: https://podcast.greenlight.guru/episode/understanding-the-investigational-device-exemption-ide-process

## Summary

David Pudwill, known as 'Mr. Regulatory,' explains the Investigational Device Exemption (IDE) process to Jon Speer, detailing when an IDE is required, the distinction between exempt, non-significant risk, and significant risk studies, and the specific contents of an IDE application. Pudwill emphasizes that while 510(k) devices often don't require clinical data, high-risk or novel devices likely will, and he outlines the 12 mandatory components of an IDE submission and the FDA's 30-day review timeline. The conversation covers strategic advice on using Q-Submissions to clarify risk determinations, managing IRB interactions, and navigating post-approval reporting requirements to ensure a smooth path to market.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=0) Introduction: David Pudwill and the IDE Process
- [2:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=121) Defining IDE and When It Is Required
- [5:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=312) Exempt vs. Non-Significant Risk vs. Significant Risk Studies
- [16:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=981) Q-Submissions and Managing FDA Disagreements
- [22:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=1336) COVID-19 Impacts on Clinical Studies
- [26:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=1615) Clinical Data Requirements for 510(k) and PMA Devices
- [30:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=1805) Contents of an IDE Application and 30-Day Review
- [35:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=2106) Pre-Submission Strategy and Timeline Management
- [46:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-31-understanding-the-investigational-device-exemption-ide-process#t=2794) Post-Approval Reporting and Study Close-Out

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- Mr. Regulatory (other)
- David Pudwill (other)
- Jon Speer (other)
- Green Light Guru Academy (other)
- 21 CFR Part 812 (other)
- Q-Submission Program (other)
- 510(k) (other)
- PMA (other)
- De Novo (other)
- IRB (other)

## Related episodes from other shows

- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (Let's Combinate)
- [104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w) (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/2021-03-31-understanding-the-investigational-device-exemption-ide-process. 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.