Connell said registration establishment fee exemptions have never been provided wholesale to individual companies. "Lack of clarity in previous agreements had led certain types of establishments to operate without paying establishment fees in the past," he said. He gave the examples of distributors and electronic medical records companies.

These types of establishments have been explicitly incorporated into the fee-paying system under MDUFA III, according to Connell. In addition, the new law says that are no exemptions: "There are no waivers or fee reductions for small businesses. Starting in fiscal 2013, all establishments must pay registration fees, regardless of establishment type or activities conducted," said an official statement from the FDA.

An FDA spokesperson confirmed this with DOTmed News.

Besides the new registration fees, there are increased fees for device companies applying for 510k submissions, premarket approval (PMA) and other types of procedures. These types of fees have increased through the years, and will continue to escalate for fiscal 2013. For example, in fiscal 2012, the standard fee for a 510k submission was $4,000, or 2,000 for a small business fee ($100 million or less in gross receipts or sales). For fiscal 2013, it's 4,960 for a standard fee and 2,480 for small business.

"Fees are going up on all parts of it. That's a big cost for the industry, but a fully functioning FDA is worth a lot to the industry," said Connell.

The trend of fees going up worries McCrary.

"It bothers me that this is the beginning of something that will become bigger and my worry is it will drown out the people such as small businesses with the fees," she said.

According to James O'Reilly, a professor at University of Cincinnati College of Law and chairman of the FDA committee of the American Bar Association, the new fees could certainly have an impact on small and mid-sized medical device companies.

"It will impact their willingness to bring on an additional invention or additional new or novel device," he said.

Other provision in the law to plan for

O'Reilly told DOTmed News that FDA inspections will be more high-risk under the new law, and that companies should be prepared for this.

"It's especially high-risk for those who have multinational supply chains because the component plants outside the U.S. operate in a different culture relating to their government inspectors," he said.

For instance, if an FDA inspector shows up unannounced in a country outside of the U.S. and the people in that plant are not trained to respond appropriately to the inspector causing them to be turned away, the company could risk having a delay or refusal from the inspector that would result in a barrier of the foreign components into the U.S.

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