If your company is outside the United States and does not have a physical address in the country, SANRUBIO can be your US Agent before the FDA.
Please note that the US Agent has no responsibility related to the reporting of adverse events under the Medical Device Notification Regulation (21 CFR Part 803) or the submission of 510(k) Premarket Notifications (21 CFR Part 807 , Subpart E).
OUR US AGENT SERVICE INCLUDES:
task_altAssist FDA in communications with the foreign establishment.
task_altRespond to questions related to the foreign establishment's devices being imported or offered for import into the United States.
task_altAssist FDA in scheduling inspections of the foreign establishment.
task_altIf FDA is unable to contact the foreign establishment directly or expeditiously, we will receive any information or documents that FDA sends to the foreign establishment.
OUR TEAM OF PROFESSIONALS IS READY TO HELP YOU
