Slide 1: US FDA's Electronic Submission Template and Resource (eSTAR)
US FDA’s Electronic Submission Template and Resource (eSTAR) An evaluation of best practices and recommendations on utilizing eSTAR & Copyright © Veeva Systems 2023 1
Slide 2: Speakers
Patrick Axtell Assistant Director, Tools and Templates Team, FDA Ayesha Shah Director of Regulatory Strategy, Veeva MedTech Jonathan Gaynor Senior Solution Consultant, Veeva MedTech
Slide 3: Agenda
Agenda 1 eSTAR Overview 2 Evolution of eSTAR 3 eSTAR Benefits 4 Recommendations for using eSTAR 5 The Future of eSTAR 6 Q&A Copyright © Veeva Systems 2023 3
Slide 4: eSTAR Overview
eSTAR Overview • “Electronic Submission Template and Resource” (eSTAR) is an interactive submission template created by FDA that will be the ONLY way to submit 510k(s) starting October 1, 2023 (unless exempt). • eSTAR is free and available for use for 510k(s), De Novo requests and Pre-Submissions •
Slide 5: Background
Background eSTAR template for “Quality in 510(k) Review general, voluntary use Program” and final guidance for eSubmitter eSTAR 2018 2022 2021 2023 Draft Guidance on eSTAR was October 1, 2023 CDRH will released & eSubmitter was require all 510(k)s to utilize discontinued eSTAR (unless exempted) Copy
Slide 6: Benefits of eSTAR
Benefits of eSTAR Follows the Intuitive, guided Automation- Eliminates the content of SMART workflows, relevant fields are need for an eCopy templates utilized integrated populated based validation & RTA by reviewers databases on answers to assessment initial questions Copyright © Veeva Systems 2023
Slide 7: eSTAR Quick Tips
eSTAR Quick Tips eSTAR is free, but ensure your organization has Adobe Pro, 2017, DC or Foxit Study the eSTAR template & website in advance of your submission. Learn the format of the template, navigation, help features, and limitations Validate responses to the “Application/Submission Type” & “Devi
Slide 8: Additional Recommendations
eSTAR Additional Recommendations Establish a single Utilize the export/import source of truth for xml data function for submission source submission backup, saving files and future submissions Review current processes for Monitor the eSTAR Establish a process for website to check for tips, technical
Slide 9: Future State
eSTAR Future State 1 2 3 FDA/Health Canada joint “Hypothesis” is that PMA is planned as the next pilot & Health Canada only additional markets will submission type pilot underway conduct pilots Copyright © Veeva Systems 2023 9
Slide 10: Next Steps?
Next Steps? Going to RAPS? Visit Veeva MedTech at Booth #501 Or email us: estar@veeva.com to see a demo of Vault RIM eSTAR capabilities! For regulatory process or content questions please email: USFDA: DICE@fda.hhs.gov Health Canada: meddevices-instrumentsmed@hc-sc.gc.ca Copyright © Veeva Systems 20
Slide 11: Questions
2 Questions