# How to Choose the Right FDA Regulatory Pathway for your Device

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-02-26
- Length: 38m
- Episode: 135
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device
- Listen: https://podcast.greenlight.guru/episode/how-to-choose-the-right-fda-regulatory-pathway-for-your-device

## Summary

Mike Drues of Vascular Sciences joins host John Spear to explain that medical device companies have 7 major FDA regulatory pathways, including 510(k), PMA, De Novo, HDE, PDP, CDE, and EAP, rather than just the two commonly known options. Drues details how classification depends on both technology and labeling, allowing companies to 'wordsmith' claims to access different routes, such as using a Humanitarian Device Exemption (HDE) for narrow patient populations or a Custom Device Exemption (CDE) for personalized 3D-printed devices. The discussion highlights strategic combinations, such as using an Emergency Access Program (EAP) for early feasibility data before a full PMA, or pursuing anatomy-specific pathways for the same device. Drues also clarifies that programs like Breakthrough Devices Program (BDP) and Safer Technologies Program (STEP) are not standalone pathways but efficiency accelerators for standard submissions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=0) Introduction: Mike Drues and Vascular Sciences
- [1:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=119) The 7 Major FDA Regulatory Pathways and Sub-pathways
- [7:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=422) The Medical Device Pyramid: Classification, Risk, and Labeling
- [13:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=794) 510(k), De Novo, and Product Development Protocol (PDP)
- [20:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=1219) Humanitarian Device Exemption (HDE) and Label Expansion
- [23:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=1386) Custom Device Exemption (CDE) and Personalized Medicine
- [29:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=1750) Emergency Access Program (EAP) and Ethical Considerations
- [32:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device#t=1972) Breakthrough Devices Program (BDP) and STEP Clarifications

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- 510(k) (other)
- PMA (other)
- De Novo (other)
- HDE (other)
- CDE (other)
- EAP (other)
- BDP (other)
- STEP (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)
- [118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-10-118-what-are-drug-device-master-files-and-when-to-use-for-combination-product-su) (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)
- [131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-10-131-novel-sterilization-methods-for-drugs-devices-combination-products-ema-decis) (Let's Combinate)
- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (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/2020-02-26-how-to-choose-the-right-fda-regulatory-pathway-for-your-device. 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.