The long road to FDA clearance

The holy grail for medical devices in to clear US FDA.  Perfint healthcare and Forus healthcare are working on the process on getting the clearance to expand into the US market. Both of them are at different stages of the clearance process.

Both the companies are working on the 510(k) route. It is based on medical devices similar to yours that have already received 510(k) clearance from the FDA, called “Predicate Devices. The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well.

The Emergo Group performed an analysis of publicly available FDA 510(k) data pulled from the FDA website.

• The analysis has shown that 95-97% of all 510(k) applications cleared by the FDA occur within one year of initial submission date.
• The number of 510(k) submissions submitted in 2011 which cleared within 3 months increased to 42% from 40% and the average number of days decreased to 138 days.

The average time for approval for various devices is as follows.

One important factor to keep in mind is that the FDA does not "approve" medical devices; they "clear" them for sale in the US. One could have a product that has been sold across the world, with doctors using them regularly, but for the product to be sold in the US it has to be cleared first by the US FDA. Given the size of the US market and their focus on reducing the overall cost of healthcare, it is an opportunity that is very difficult to ignore dispite the pain.