In 2012, the Food and Drug Administration (FDA) passed a new act, the Medical Device User Fee Amendments, which went into effect on October 1. The new act, according to the FDA, “includes performance goals and user fees paid to the FDA by medical device companies when they register and list with the FDA and when they submit an application to market a medical device in the U.S.” In the long run, the new act will help to shape with way that the FDA approves products, clinical trials, and also shorten timelines for scheduling appeals of meetings or decisions. It also will change the process for the reclassification of devices.
The provision that medical device manufacturers pay fees to the FDA when they register their establishment and list their devices first went into effect in 2002. They must pay fees whenever they submit an application or a notification to market a new medical device. The Medical Device User Fee Amendments (MDUFA III) that were passed in 2012, a decade after the fee schedule first went into effect, were meant to further regulate the approval and medical devices, despite fees that were being paid to the FDA. According to the FDA, MDUFA III “is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives.”
With the new amendments, the FDA will take in approximately $595 million (accounting for inflation) in user fees over the five years. More workers will be hired to the FDA to help administer the new regulations, and the FDA is expected to add 200 jobs because of it.
This year will tell if MDUFA III truly helps consumers to avoid defective medical products through better FDA regulation. Yet there's no chance that it can completely erase the risk of receiving faulty medical equipment. If you or someone you know received defective medical devices, you may be eligible for compensation. Contact an experienced Chicagoland attorney today.
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