FDA Amendments Act Expands Agency’s Authority over Medical DevicesFDA Amendments Act Expands Agency’s Authority over Medical Devices
October 1, 2007
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.
FDA's von Eschenbach: Continuity and enhancement.
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.
Annual establishment registration fees to be paid by all domestic and foreign medical device manufacturers, reprocessors, and establishments that develop specifications for devices that are distributed under the establishment's name, but that perform no manufacturing.
Annual registration fees for filing periodic reports relating to PMA-approved devices.
Fees for 30-day notifications of device modification.
Fees for 513(g) classification requests.
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.
Provides incentives for medtech manufacturers to develop devices specifically targeted to the pediatric population.
Requires registration of all medical device trials with the National Institutes of Health's clinical trial data bank.
Promotes the development and promulgation of regulations establishing a unique identification system for medical devices.
Calls for improving and streamlining FDA's third-party inspection program.
Directs the U.S. comptroller general to conduct a study of the FDA 510(k) review process to determine the safety and efficacy of predicate devices.
DLA Piper's Rathvon: Outcome still unknown.
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.”
MDMA's Leahey: Reasonable reductions made.
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.
Application Fee Type
FY08 Standard Fee ($)
FY08 Small-Business Fee ($)
Premarket approval (PMA) application
Premarket notification submission 510(k)
513(g) classification request
Annual fee for periodic reporting on Class III devices
Annual establishment registration fee
Table I. FDA's standard and small-business medical device user fees for fiscal 2008, by application type. Fees are effective for all of the listed application types submitted to FDA from October 1, 2007, through September 30, 2008. Source: "Medical Device User Fee Rates for Fiscal Year 2008," Federal Register 72, no. 197, FR: 58099-58102 (October 12, 2007).
© 2007 Canon Communications LLC
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