Electronic Submission Template for Medical Device 510(k) Submissions
On September 28th, FDA published draft Guidance on the ”Electronic Submission Template for medical device 510k Submissions”, which will remain open for public consultation for 60 days.
The Guidance introduces the electronic Submission Template and Resource tool eSTAR, which is an automated, interactive PDF that guides a user through construction of an eSubmission.
Once the draft guidance has been finalized, the Agency will only be accepting electronic submissions for original 510(k) submissions and subsequent ones including amendments and supplements unless an exemption has been granted or the developer has received a waiver.
Read the draft guidance.
Meditrial offers regulatory consulting. We have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies from around the world. Contact us for an expert advice!
Table of Contents
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
