FDA 510(k) eSTAR Electronic Submission Template Explained

eSTAR (electronic Submission Template And Resource) is the FDA’s electronic submission template tool for medical device 510(k) submissions. It is mainly used to standardise the format and content of submissions so that the FDA can review them efficiently.

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 1

The home page when the electronic submission template is opened:

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 2

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 3

Submission type

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 4

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 5

The submission types and the sections of content in the eSTAR

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 6

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 7

END

That concludes our introduction to the eSTAR electronic submission template used for FDA medical device submissions. If you need help with registration regulations or practical work, we are happy to provide professional services.

This article is part of our series of FDA educational content. Everbiz is committed to sharing medical device expertise with industry clients and, drawing on extensive hands-on experience in quality systems and product registration, providing practical help to jointly advance the medical device industry.

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 8

More articles:

China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices

Detailed Guide to the Medical Device Classification Determination Procedure

The Complete Australian Medical Device Registration Process Explained

Clinical Evaluation Routes and Methods in MDR Certification

Guide to Writing MDR Technical Documentation

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 9

About Us

COMPANY INTRODUCTION

EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 10

Our Offices

COMPANY ADDRESS

Shanghai: Room 705, Building 6, Lane 111, Luxiang Road, Baoshan District, Shanghai | Germany: Landsberger Str. 155, 80687 München, Germany

Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria

Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong

Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 11

FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained – Figure 12