![]() ![]() eSTAR is also voluntary for medical device PMA and Pre-Submissions to CDRH.ĮSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review. eSTAR is voluntary for medical device De Novo submissions to CDRH or CBER. This requirement includes 510(k) combination products and Dual 510(k)/CLIA Waiver IVD submissions. Serves as a comprehensive resource to consolidate the necessary information and links needed for submission preparation.ĮSTAR is free and is required for all medical device 510(k) submissions, unless exempted, to the Center for Devices and Radiological Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER).Collects submission data in a structured format to help automate many aspects of FDA processing.Includes built-in forms (Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881). ![]() Includes built-in databases to ensure the information relevant for device specific guidances, classification identification, and standards information are auto filled accurately. ![]()
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