# Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-07-27
- Length: 44m
- Episode: 273
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance
- Listen: https://podcast.greenlight.guru/episode/examining-fdas-refusal-to-accept-rta-policy-and-guidance

## Summary

Mike Drues of Vascular Sciences, joined by hosts Jon Speer and Etienne Nichols, explains the FDA’s Refusal to Accept (RTA) policy, noting that approximately 60% of 510(k) submissions are rejected during administrative review due to company errors. Drues highlights that while electronic tools like eSTAR help organize submissions, they do not evaluate content quality, leading to rejections for missing sections, inconsistent labeling, or failure to use current forms. The discussion emphasizes that companies must proactively explain 'Not Applicable' sections and treat the FDA as a customer rather than a beta tester to avoid delays.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=0) Introduction: Mike Drues and the FDA RTA Process
- [1:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=85) The Two-Step Review: Administrative vs. Substantive
- [8:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=506) RTA Checklists and Rejection Statistics
- [17:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=1050) The Role and Limitations of eSTAR and E-Tools
- [24:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=1489) Common Administrative Errors: Missing Sections and Forms
- [30:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=1856) Device Description and Draft Guidance Compliance
- [36:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=2195) Treating the FDA as a Customer and Telling a Story
- [40:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance#t=2412) Handling RTA Rejections and Pre-Submission Strategies

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- FDA (company)
- Vascular Sciences (company)
- Green Light Guru (company)
- eSTAR (tool)
- 510(k) (product)
- De Novo (product)
- PMA (product)

## 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)
- [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)
- [069 - EU MDR Extension with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott) (Let's Combinate)
- [137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use) (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/2022-07-27-examining-fdas-refusal-to-accept-rta-policy-and-guidance. 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.