Fees for Medical Devices
The Food and Drug Administration Safety and Innovation Act was signed last week by President Obama. This act includes user fees, which will be paid by medical device companies to the FDA. The reason for the fees is so the FDA can increase its performance in researching and approving licenses for new medical devices that have been trying to hit the market. According to critics, the FDA takes too long to pass licenses to certain medical products. Whether it is a product being by medical employees while they routinely cath a patient or a senior citizen at home with a hearing aid, these products must be thoroughly examined for safety.
Are the Fees Worth It?
Medical device companies have been paying FDA fees since 2003 in the hopes of speeding the license process up. These fees have obviously expanded the FDA’s budget but critics still complain that they have not seen license applications being approved any faster. The new Act signed by President Obama will increase the funds the FDA receive in hopes they begin working faster to approve new medical devices.
Are Devices Safe?
We need to realize that medical devices in the United States remain very safe and are rarely recalled. I feel that this has a lot to do with the FDA’s thorough process of only approving applications for devices that are safe for use. I feel the only way for the FDA to be more effective is to hire more inspectors so that more people are reviewing and processing medical device applications. Training needs to be very strict and intense so that all medical devices used in the United States remain safe and recall rates remain low.
It makes sense that the more complicated the device, the longer the application takes. If a nurse is to cath me after surgery, I want to make sure that it functions as it’s supposed to and is free from contamination. Moreover, if I’m having open-heart surgery and having a heart valve installed, I want it to be the best and most effective heart valve on the market. I fear that if we begin to put too much pressure of the FDA to speed up their processes faulty products are going to hit the market.
Instead of criticizing the process, I suggest we make the request that the FDA focus the funds on the training of new inspectors so that productivity can increase with the FDA. We need to understand that the process will take some time until we see improvements.