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. Complaint Handling 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. ABOUT US Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English