The FDA is constantly recruiting personnel to test the Customer Collaboration Portal (CCP) functionality. This portal is already active to check the procedures status and it will soon be implemented for uploading Medical Devices pre-market authorization dossiers, including traditional, abbreviated or special 510(k) procedures. The uploaded documents can be in both eSTAR and eCopy formats.

One of the major requirements that the FDA aims to meet is the portal security: the platform is programmed so that only the Official Correspondent, who is also the account holder responsible for monitoring and uploading on the platform, can see the development of the information.

Which are the advantages of dossiers uploading?

Thanks to a standardized format, producers are assured that the information of their 510(k) procedure is complete, while the FDA reviewer can carry out checks in a rapid and effective way. Particularly, the use of the eSTAR electronic model will significantly improve the quality of the 510(k) delivery.

>>> Do you need support to market your devices in the USA?

With our regulatory strategic advisory service and pre-market USA registration support, including 510(k) procedure, Thema can support you by fulfilling the pre- and post-market requirements of 21 CFR and of the federal regulation, enabling smooth and efficient device entry and distribution.

Furthermore, with the Local Representative U.S. Agent service and U.S. Initial Importer required for the establishment registration you can market your devices independently.

Contact our Customer Service for further information.