There are several ways medical devices may be cleared for marketing in the US. Perhaps the most common is called the "Premarket Notification" or 510(k).

This numeric and letter designation refers to a section of law which requires that advance notice of intent to market a product be given to FDA for certain (generally low-to-moderate risk) medical devices. Generally speaking, new devices can't be sold, distributed or used until the FDA reviews the information submitted and clears the device for marketing.

Conceptually, a 510(k) requires that an argument of "Substantial Equivalence" be presented to FDA contrasting the new medical device with an older "legally marketed" device. Showing "Substantial Equivalence" means a point by point comparison of the uses, characteristics and features of the device. Thus, a 510(k) is a detailed factual document provided to FDA demonstrating how a new, innovative medical device is, in reality the same as another older device that was in commercial distribution before 1976.

Clearly, care is needed when making this argument because the term "Substantial Equivalence" is undefined by FDA. Thus, the success of a given 510(k) is directly related to how well this argument is made and the skill with which the issue of equivalence is explained to the FDA reviewer. Though most 510(k)'s are not complex documents to assemble, the clear concise demonstration of "Equivalence" is not trivial and should not be left to amateurs.

The majority of 510(k)'s fall in the fee range of $1,500.00 to $3,000.00. Depending on the complexity of the device technology, the need for clinical data or statistical analysis, fees can range from $1,000.00 to $10,000.00. Estimates are provided without cost. We also offer a reduced fee "ghost writing" option for product managers or other company professionals who wish to finish a draft document, file and manage all communication with the FDA themselves. Contact us for details.