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FDA 510k Consulting – Safelink Consulting

Are you a manufacturer of medical devices?

FDA 510k is the section of the Food Drug and Cosmetic Act that requires device developers to notify FDA of their intent to market a device through submission of a Premarket Notification.

Companies intending to introduce certain classes of medical devices into the US market must submit a 510(k) to the FDA. After FDA’s clearance that medical devices can be manufactured and distributed in the US. Changes in the technology used to manufacture a device or a change in the intended use of the medical device can also require submission of a 510(k) premarket notification to the FDA.

FDA 510(k) Submission guidance – does my product need an FDA 510k?

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