International device manufacturers can find it difficult to navigate the complex regulatory pathways necessary to access the United States healthcare market. O’Connell Regulatory Consultants specializes in helping international companies, particularly small and medium sized firms that may not have a dedicated regulatory affairs department. The consultancy can determine the required regulatory submission and prepare that submission for you. The majority of medical devices are cleared by the FDA through the 510(k) process and clearance to market your device in the United States can occur as soon as 90 days after the submission is made to FDA. In addition, if your device should require another type of submission to achieve approval in the United States including Premarket Approval (PMA), O'Connell Regulatory Consultants can help you to make this determination and plan and execute your regulatory strategy.


U.S. based distributors are often seeking new products to introduce into their product lines. In many cases, these products may not yet be FDA approved. O’Connell Regulatory Consultants can work directly with the international manufacturer and assist in preparing the necessary documentation which can then be sent to FDA in order to allow the new products to be FDA cleared. Once you have an approved product, it will be allowed through customs and can be legally
sold in the United States.





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