# What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-03-12
- Length: 38m
- Episode: 136
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces
- Listen: https://podcast.greenlight.guru/episode/what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510k-review-process

## Summary

Mike Drues of Vascular Sciences explains the FDA's eSTAR (electronic Submission Template And Resource) pilot program, a PDF-based 510(k) template designed to streamline administrative reviews. He details the specific eligibility requirements, including the need for software and tissue contact, and critiques the program's lack of incentives for small companies compared to large ones. Drues argues that while eSTAR standardizes submission format, it does not reduce regulatory burden or scientific review time, comparing it to TurboTax for medical devices.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=127) eSTAR Program Overview and RTA Exemption
- [5:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=332) Comparison to Quality in 510(k) Review Pilot
- [11:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=682) Eligibility Requirements and Pilot Constraints
- [18:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=1117) Template Structure and Browser Limitations
- [23:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=1433) Incentives, User Fees, and Submission Logistics
- [27:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=1679) The TurboTax Metaphor and Value-Added Features
- [35:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces#t=2103) Final Takeaways and Future Outlook

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)

## Most relevant to

early-stage companies

## Mentioned

- FDA (company)
- Vascular Sciences (company)
- Greenlight Guru (company)
- eSTAR (product)
- TurboTax (product)
- 510(k) (other)

## Related episodes from other shows

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- [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)
- [059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-03-143-new-fda-draft-guidance-essential-drug-design-outputs-with-alan-stevens-and-r) (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/2020-03-12-what-is-the-estar-pilot-program-and-how-will-it-improve-fdas-510-k-review-proces. 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.