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Question:

From Vermont, USA:

I understand that a company has submitted a 510(K) with the Food and Drug Administration (FDA) for its new product. What is the 501(K) exactly? More importantly, how long does it generally take from the time of submission to approval (if it is approved)?

Answer:

A 510(k) is a document that manufacturers of medical-related products have to submit to the Food and Drug Administration before they can sell them in the U.S. The FDA calls the 510(k) a "premarket notification." They have to show in 510k applications that products in the category are comparable in safety and effectiveness to a device already legally marketed. FDA receives about 1,500 applications of this type a year. It generally takes several years for the FDA to approve a 510(k) -- and some of them are never approved.

DM

Original posting 14 Mar 1998
Posted to Research: Other

  
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Last Updated: Tuesday April 06, 2010 15:08:56
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