Late last month, just days before the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was set to expire, Congress overwhelmingly passed the FDA Amendments Act of 2007 (FDAAA), which reauthorized and expanded the agency's role in reviewing, approving, and monitoring medical devices. The legislation not only ensures the continuation of the medical device user fee program through 2012, but it also includes several new components and initiatives.

Commenting on the passage of FDAAA, FDA commissioner Andrew von Eschenbach, MD, said, “The act continues essential and successful programs that will enhance FDA's ability to more efficiently and effectively regulate drugs, biological products, and medical devices. It will provide enormous benefit to the public health by allowing FDA to continue to deliver safe and effective medical products to Americans every day.”

Over the course of the five-year period covered by the new law, FDA is authorized to collect approximately $287 million in user fees from medical device manufacturers. Whereas fees for pharmaceutical manufacturers increased dramatically under the new Prescription Drug User Fee Act, medtech manufacturer fees for premarket approval (PMA) applications and 510(k) notification submissions decreased when compared with the rates that expired under the old law. However, FDA will now have the authority to collect four new types of fees from medtech firms (see table). They are as follows.

FDAAA provides FDA with increased revenues for premarket device review and earmarks $39 million in appropriations over the five-year period to strengthen the agency's postmarket surveillance program. Other key provisions of FDAAA include the following.

James P. Rathvon, a partner with law firm DLA Piper (Washington, DC), says that the final FDAAA provisions were generally consistent with the expectations of the medtech industry. Noting the law's increased focus on provisions and initiatives regarding device safety, Rathvon said, “It will be some time before we know the full outcome of the law's provision that calls for a thorough review of FDA's 510(k) process. While there needs to be more study of the devices that come on the market through this route, I do not anticipate FDA requiring clinical trials and PMA applications from manufacturers that can clearly demonstrate and document equivalence with an existing device. Any calls for PMAs over 510(k)s are likely to be just an uptick. However, given the increasing calls for greater oversight and device scrutiny prior to market approval, FDA may indeed tighten the 510(k) approval process.”

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC) also believes that FDAAA emerged largely as expected. “It's well known that MDMA was initially opposed to the concept of user fees,” he says. “However, when they became a reality in 2002, we set a course to make certain that industry did not end up funding a major portion of the program. To that end, and within that context, I think we have been successful. We're pleased that the user fees in FDAAA have been reduced. The industry's contribution is reasonable and will not create an undue burden—particularly on the small manufacturer.”

Complete information on the FDA Amendments Act of 2007 is available at www.fda.gov/oc/initiatives/advance/fdaaa.html.

© 2007 Canon Communications LLC

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