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How to prepare a submission using eSTAR.

Due to the use of automatic verification, the CDRH does not intend to conduct a Refuse to Accept (RTA) review for submissions submitted as an eSTAR. With a standardized format, submitters can ensure their submissions are complete, and CDRH can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices. The voluntary eSTAR 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 the CDRH’s premarket review. The eSTAR is not currently for use with combination products. The eSTAR is free and available for voluntary use for all medical device submitters for 510(k)s and De Novos submitted to CDRH.

Guided construction for each submission section.Integration of multiple resources (for example, guidances and databases).Content and structure that is complementary to CDRH internal review templates.

Automation (for example, form construction and autofill).The eSTAR is an interactive PDF form that guides submitters through the process of preparing a comprehensive medical device submission.