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.Auto fills entered information to avoid entering the same information twice.The FDA does not intend to conduct an RTA review for an eSTAR submission. Automates many aspects of the submission to ensure the content is present, eliminating the need for a Refuse to Accept (RTA) review by the reviewer and RTA holds. ![]() ![]() Provides a standardized format to make information accessible for the reviewer and submitter.Complements the reviewers’ internal Submission Memo And Review Template (SMART) used to review the submission (the questions correlate), so the reviewer is getting what is expected.Guides the submitter to ensure they provide the necessary details for the submission.ESTAR is now available for voluntary use for the following Premarket Approval Applications (PMAs) submission types:Īll 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the final guidance: Electronic Submission Template for Medical Device 510(k) Submissions.ĮSTAR is the only available electronic submission template to prepare 510(k) electronic submissions.ĮSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.
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