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New Act Will Help FDA Regulate Medical Manufacturers

Last month, President Barak Obama signed into law the MDUFA III – the Medical Device User Fee Act – which provides funding, as well as some new requirements, to the FDA. While the new version of the act does not go into effect until Oct. 1, several deadlines are now in place.shutterstock_566212006

As of this past Monday, August 6th, the FDA will officially receive funding for the next five years through this law for improved medical device reviews and increased device safety.

When medical device manufacturers register a new or changed device for FDA approval, they have to pay a tax, which funds the MDUFA. Consumer groups have criticized this system, saying the tax is a way for manufacturers to pay for their own regulations. With MDUFA III, however, part of the tax will go to fund hiring 200 new full-time workers to increase safety testing and regulation reviews.

The new MDUFA also requires the FDA establish a Unique Device Identifier (UDI) system within 2 years. This system would track reports of defective devices more efficiently. The UDI is a device number used to track devices, much like VIN numbers in car manufacturing.

However, the new act will restrict the FDA’s authority in some areas. For example, sometimes the FDA does not approve a drug or device based on a questionable history, but the new MDUFA allows device makers to apply for an Investigational Device Exemption, and market the product anyway. The act has also come under fire from consumer lobbies because it does nothing to regulate the current 510(k) legislation, which allows manufacturers to fast-track devices to market without full FDA approval, based on an existing device – even if that device is faulty.

For example, the ProteGen vaginal mesh device has served as the template for all mesh repair devices currently on the market, but the ProteGen itself was recalled in 1999.

The FDA exists to help protect consumers from defective products and drugs, but its powers are limited. Doctors and manufacturers must report defects, and until the UDI system is in place, these reports have no centralized system to categorize them. Sometimes, it can take the FDA years to recall a defective product because the agency cannot realize the full extent of the problem. In the meantime, more and more consumers suffer the consequences. Defective medical devices can cause serious side effects that can drastically change a patient’s life, and sometimes even result in death.

The personal injury lawyers at the Strom Law Firm can help. We are currently accepting cases nationwide against Transvaginal Mesh Device manufacturers, as well as Takeda Pharmaceuticals, manufacturers of the controversial diabetes drug, Actos. We accept a variety of other personal injury cases as well, so please contact us today for a free consultation. 803.252.4800. We can help get you on the road to recovery.



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