Knowledge Center

FDA 510k Approval Consultation

Organizing and submitting a 510k application can be challenging and the repercussions of an incomplete application can include millions of dollars wasted due to delays in product-to-market operations.

Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration (FDA), which means you likely need to submit a 510(k).

A 510(K) is a premarket submission to notify the FDA at least 90 days in advance of an organization’s intent to market a regulated product.

Want to know more? – read this associated post.