# #346: FDAs eSTAR Program

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-11-30
- Length: 47m
- Episode: 346
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program
- Listen: https://podcast.greenlight.guru/episode/346-fdas-estar-program

## Summary

Patrick Axtell from the FDA, along with Lisa Pritchard and Kathy Herzog from DuVal & Associates, discuss the mandatory eSTAR program for 510(k) submissions. They explain how the standardized template automates data collection, integrates guidance documents, and eliminates the Refuse to Accept (RTA) checklist to streamline reviews. The experts share strategies for building advocacy through the executive summary and managing attachments offline to avoid common pitfalls like missing content or formatting errors.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=0) Introduction and Guest Origins
- [4:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=251) The eSTAR and I Concept and History
- [9:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=577) Purpose and Benefits of eSTAR
- [15:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=918) Industry Reception and AI Potential
- [18:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=1093) Strategies for Using eSTAR Effectively
- [29:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=1743) Pitfalls and Workflow Best Practices
- [38:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-30-346-fdas-estar-program#t=2323) RTA, Reviewer Challenges, and Future Roadmap

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- DuVal & Associates (company)
- Greenlight Guru (company)
- eSTAR (tool)
- 510(k) (other)
- De Novo (other)
- PMA (other)
- Health Canada (company)

## 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)
- [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)
- [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)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)
- [242 - LIVE from Austin, TX with Casey Nakamura](https://hardwarepodcasts.com/podcast/people-of-packaging/2024-02-01-242-live-from-austin-tx-with-casey-nakamura) (People of Packaging)

## 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/2023-11-30-346-fdas-estar-program. 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.