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
Maintaining an office in the United States can be a costly expense for the foreign establishment exporting to the United States. Your complaint files will be the first place an FDA inspector will begin their audit of your facility. Together with failing to register adverse effects through the electronic reporting system known as the eMDR, this is the single most frequent 483 observation (deficiency) that occurs in foreign establishments.
All manufacturers must maintain complaint files according to CFR 820.198. Smith Associates can add this service to your US Agent agreement.
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.