The US market can be a challenge for companies looking to sell their medical devices into the largest market in the world. They must engage with experts with the relevant knowledge and experience to ensure a smooth and efficient regulatory process to acquire an FDA 510(k).
A 510(k) is a premarket notification that must be submitted to FDA, demonstrating that the device to be marketed is safe and effective. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance.
Our medical device regulation consultants have experience in submitting device approval/clearance applications to the FDA and can guide clients through the whole process, from start to finish.
If you’re looking to expand into the US market and acquire an FDA 510(k), then contact us so that we can help you on your journey.