What is Non-In Vitro Diagnostic (nIVD) eSTAR for 510(k) Submission?

Non-in vitro Diagnostic (nIVD) eSTAR refers to a standardized electronic Submission Template And Resource (eSTAR) used for submitting regulatory information for non-in vitro diagnostic medical devices to the FDA (Food and Drug Administration), mainly the 510(k) documentation. This template is designed to streamline and facilitate the submission process by providing a structured format for the required information.

Example of nIVD eSTAR

Suppose a company has developed a new type of insulin pump to assist diabetes patients in managing their blood glucose levels. The company must obtain U.S. FDA clearance to market this device in the United States. The submission process involves providing detailed information about the device, including its design, manufacturing, and clinical data demonstrating its safety and effectiveness.

Using the nIVD eSTAR template, the company would:

1. Product Description: Provide a detailed description of the insulin pump, including its intended use, technological characteristics, and the components involved.
2. Performance Testing: Submit data from performance tests, including bench tests and any applicable clinical studies, to show that the device performs as intended.
3. Biocompatibility Testing: Include results from biocompatibility testing to ensure that materials used in the device are safe for contact with human tissue.
4. Software Documentation: If the insulin pump includes software, the company must provide documentation and testing data to demonstrate that the software is reliable and performs correctly.
5. Labeling: Provide copies of the device labeling, including instructions for use, warnings, and contraindications.
6. Manufacturing Information: Include details about the manufacturing process, quality control measures, and compliance with relevant standards.
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The nIVD eSTAR template organizes these sections in a standardized format, making it easier for both the submitter and the FDA to review and process the Submission efficiently.

In summary, the nIVD eSTAR is a tool for 510(k) submission ensuring that regulatory submissions for non-in vitro diagnostic medical devices are comprehensive, organized, and compliant with FDA requirements.