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FDA Expands the Functionalities of the CDRH Portal
(Thursday October 3, 2024) The submission and tracking portal maintained by the Center for Devices (CDRH) at the FDA is an enhanced tool for not only the electronic submission of almost all device applications but also for tracking the progress of the review and interacting with the FDA reviewers. This week, the FDA added more functions to it. The CDRH Customer Collaboration Portal, or CDRH Portal, was created about 2 years ago as a tool for electronic submissions of market approval applications. It is different from the Electronic Submission Gateway (ESG) used for almost all non-device submissions to the FDA. Unlike the ESG, the CDRH Portal also allows tracking of the progress of the review. At this time, except for the IDE, all applications for medical devices can be submitted through the Portal. It has been a great success with positive feedback from most submitters. Starting this week, one can also submit Small Business Determination (SBD) requests and track the progress of PMA applications, both original and supplements. Submitters no longer need to submit a physical cover letter to the FDA after uploading an electronic submission to the CDRH Portal. The Portal is limited in accepting files smaller than 4GB or PDF files with attachments larger than 1GB, but that does not affect most submissions as few applications have individual files or entire submissions larger than these limits. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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