| 
Updated eSTAR Now Available As part of the U.S. Food and Drug Administration's (FDA) ongoing work to strengthen the premarket review program, the Center for Devices and Radiological Health (CDRH) is providing an updated Premarket Submissions page to make it easier to find content about premarket submissions. The updated Premarket Submissions page links to information to help manufacturers with selecting and preparing the correct premarket submission type and sending a premarket submission to CDRH. The eSTAR has been available for all manufacturers to voluntarily submit 510(k) submissions since September 8, 2020. As part of process improvements, the eSTAR for 510(k) submissions has been updated to provide additional instructions and clarifications. CDRH has also incorporated capabilities to also preview eSTAR information for De Novo requests. At this time, the De Novo eSTAR is being provided for viewing purposes so manufacturers can review and become familiar with the content and compile a De Novo request, consistent with the De Novo final rule published on October 5, 2021, for submission to CDRH. Do not use the eSTAR if you intend to submit a De Novo request before January 3, 2022, as it is intended only for preparing De Novo requests for submission on or after January 3, 2022. January 3, 2022 is the effective date of the De Novo final rule which published on October 5, 2021. These updates are part of the Center for Devices and Radiological Health's Digital Transformation Initiative, which includes improving the user experience and saving time and resources for customers both internally and externally to the FDA as one of its goals. Questions? If you have questions, contact the Division of Industry and Consumer Education. | 
No comments:
Post a Comment