UNITED STATES AGENT SERVICES
Establishment and Device Registration
Under the Code of Federal Regulation 807.40(b) the Food and Drug Administration requires a foreign establishment to designate a United States Agent to act as their official correspondent.
Smith Associates has been serving the Medical Device Industry since 1994 assisting companies large and small in receiving Food and Drug Administration clearance for new devices.
We have a proven track record assisting medical device companies in regulatory compliance. As United States Agent for your company, we can ensure compliance with the new regulation, which became effective February 11, 2002.
Additional US Agent Services
Complaint Handling and eMDR Submissions
Complaint Handling
eMDR- Electronic Submission of MDR
(Medical Device Reporting)
As of August 14, 2015, the FDA published a Final Rule: Medical Device Reporting; Electronic Submission Requirements requiring manufacturers and importers to submit their device MDR reports electronically to CDRH. Electronic reporting is also available to user facilities, but the rule permits user facilities to continue to submit written reports to the FDA.
As part of our US Agent service Smith Associates can assist the low-volume MDR submitter by electronically submitting your MDRs through our gateway portal. This service is helpful for the international client with infrequent need to submit a medical device report to the FDA.