A European medical device company with a state of the art prosthetic device, interested in breaking into the US market with its first below-the-knee prosthesis for amputees.
Our client was in the process of negotiating a distribution agreement with a US company, but did not have the US regulatory device expertise needed for Class I and II prosthetic devices.
The language barrier presented an additional hurdle in navigating the required FDA processes.
MLC developed a regulatory strategy and drafted, reviewed and submitted a 510(k) premarket notification to FDA for a robotic mobility system. Questions posed by the Agency were managed through MLC, which engaged translators as needed to ensure smooth and precise communications between ourselves, the client and regulators.
The End Result
Requirements by the FDA were satisfied with inclusion of the device description (including components and accessories), intended use and proposed labeling. In less than six months, the medical device was cleared to market by the FDA for sale in the US.