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Regulatory

510k Process

Our consultants have over 100-years of FDA regulatory and sales/marketing backgrounds and business ownership. They understand not only the regulatory side of your submission but also the marketing side. They understand the financial pressures placed on all businesses when trying to comply with FDA regulatory requirements and the costs of having to perform expensive testing in order to demonstrate the safety and effectiveness of your device compared to that of your chosen predicate . At the end of the 510k process, it is important to ensure your cleared marketing claims provide your salesforce or distributors the necessary sales claims to be competitive and compliant with all governmental regulations.

We have had over 280 successful 510(k) clearances across all CDRH reviewing Branches.

Product Classification

The first steps in product development (concept and feasibility) are determining if there is a market for your product, can your device achieve its’ financial objectives and what are the regulatory burdens for achieving FDA 510(k) or PMA clearance.
It is just as important for our group, as it is for you, to determine if we are the right consulting firm to assist you through this FDA clearance process. We provide FREE product classification, product code and quality system requirements for your medical device.
All of our review processes are transparent with the client. You will be informed in real time during the review process and FDA interaction. All submissions and correspondence are your property.

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.

We have 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 of assisting manufacturers with their regulatory compliance issues. As the United States Agent for your company, we can ensure compliance with all regulations.

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 when foreign establishments sell their products in the US.

Complaint Handling

All manufacturers must maintain complaint files according to CFR 820.198. We will 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, we 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 an infrequent need to submit a medical device report to the FDA.

Initial Importer

Identification of who will be receiving the company’s product for sale in the US is part of the foreign manufacturer’s registration.
As part of the registration of the foreign manufacturer is the identification of who will be receiving the company’s product for sale in the US. This is officially known as the Initial Importer. This may be a company that wants to sell your product (distributor) or an Initial Importer who is simply your FDA registered Initial Importer for the warehousing and shipping of your product, the main point is that someone in the US must be designated to properly receive your goods, log any issues, track serial or lot numbers and ensure compliance with FDA regulations.
Marketing in the US is a daunting task and will normally take many different avenues to sales, through regional distributors, independent sales rep, etc. The initial importer is your central receiving warehouse, freeing the foreign company to engage as many different distributors as you wish for sales without requiring these various sales entities to register with the FDA. The Initial Importer must be compliant to QS Part 820 for their services, registered with the FDA and also available for FDA inspections. Most distributors want none of this FDA involvement in their company and look to the initial importer to take on this burden.
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