The eSubmitter template was developed by FDA as an optional free tool consisting of a collection of questions, text, logic, and prompts that guides a user through...

2024年9月23日 · Use the following instructions to download the form if you encounter an issue: Forms associated with 510 (k) submissions.

2023年10月2日 · This guidance provides the standards for the submission of premarket notification (510 (k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for...

89 templates to facilitate the preparation, submission, and review of regulatory submissions for 90 medical devices solely in electronic format. As described in the 745A(b) device parent guidance, 91 FDA plans to implement the requirements of section 745A(b)(3) of the FD&C Act with

2021年9月29日 · FDA is issuing this draft guidance to introduce submitters of premarket notification (510 (k)) submissions to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed to support 510 (k) electronic submissions to FDA.

2022年10月6日 · Nearly one year after FDA published a draft guidance on its Electronic Submission Template for Medical Device Submissions (see our blog post here), the Agency is back to formally introduce the widespread implementation of the electronic Submission Template And Resource (eSTAR) electronic submission template for 510(k) submissions. eSTAR will be ...

2023年12月15日 · Starting October 1, 2023, all 510 (k) submissions, unless exempt, are required to be electronically filed through eSTAR. This electronic system is specifically tailored as an interactive PDF document for assembling a comprehensive pre-market submission of medical devices intended for FDA 510 (k) clearance within the United States.

03.01.01 Submitting to the FDA This document describes the different way a submission can be sent to the FDA. It applies to clinical research (IND/IDE) and also to Expanded Access of drugs and devices.

The following templates recommend elements to include in certain DMF submissions: In these letters, list the submission type and, if applicable, the amendment type as laid out below: DMF...

At Duke University, device eCopy premarket submissions directed to the Center for Devices and Radiological Health (CDRH) at FDA are submitted through the CDRH Customer Collaboration Portal (CDRH Portal). All Duke-sponsored IDEs must be reviewed and submitted to FDA by the Duke Office of Regulatory Affairs and Quality (ORAQ).