In a recent announcement, the Food and Drug Administration (FDA) has unveiled the availability of its innovative eSTAR tool for select voluntary Premarket Approval (PMA) submissions related to medical devices.
Earlier in October, the FDA had mandated the use of eSTAR for 510(k) medical device submissions, accompanied by the release of a comprehensive Guidance Document. Designed as an interactive PDF form, eSTAR functions as a guiding tool for applicants, facilitating the preparation of thorough medical device submissions. Its primary goal is to enhance industry consistency and streamline the FDA’s review process for greater efficiency.
The FDA highlights several advantages of the eSTAR tool, including its ability to guide submitters in providing essential submission details, aligning with the internal Submission Memo And Review Template (SMART) utilized by reviewers. This alignment ensures that the reviewer receives the expected information, promoting a standardized format that enhances accessibility for both the reviewer and submitter.
Key benefits of eSTAR also include automation features that eliminate the need for Refuse to Accept (RTA) reviews and holds. The tool auto-fills entered information, reducing redundancy, and incorporates built-in databases for accurate auto-filling of device-specific guidance, classification identification, and standards information. Additionally, eSTAR includes various built-in forms, such as the Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881.
By collecting submission data in a structured format, eSTAR plays a pivotal role in automating numerous aspects of FDA processing, serving as a comprehensive resource for consolidating essential information and links required for submission preparation.
Recognizing the potential of eSTAR, the NCBFAA Regulatory Agencies Committee (RAC) considers it a promising tool for the trade. The committee sees it as a potential precursor to determining the admissibility of imported medical devices and welcomes the FDA’s ongoing efforts to develop tools that enhance the vetting and accuracy of FDA data before the entry of medical devices into the U.S.
