The Food and Drug Administration has announced that it will be increasing the fee rates and payment procedures for medical device user fees by 4.2%.

What is the Medical Device User Fee?

Originally established in 2002 by the Medical Device User Fee and Modernization Act, device user fees are paid to the FDA by companies when registering their devices with an agency, submitting an application or a notification to market a new medical device in the U.S. and other types of submissions.

The Medical Device User Fee is a fee that the FDA charges medical device manufacturers for obtaining approval. There are 2 main types of approvals:

  1. 510(k) application – Most device manufacturers fall in this category and will be impacted. They will have to pay this fee for every product family they want to approval for sale in the US.
  1. PMA – This type of application is submitted for novel technology/product. The fee is quite steep and a 4% increase will be significant.

According to the FDA’s website, Medical Device User Fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.

How will this impact the Device industry?

This new Medical Device User Fee will be implemented on October 1, 2015 and run through September 30, 2016. The new fee will impact every device manufacturer, large and small, that wants to sell their product in the U.S.

According to Mass Device, the user fee for a 510(k) premarket notification submission will now be $5,228 in comparison to $5,018 and PMA applications will cost $261,388 rather than the $250,895 it has been this past fiscal year.

Although small businesses are able to receive a reduced fee, they are still subject to this 4.2% increase. According to the Federal Register, the increase of these user fees will bring in around $137.7 million for the FDA.

In order to avoid the increased user fee, it is best to submit your medical device applications before October 1, 2015.

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