The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Summary

The Food and Drug Administration (FDA) is responsible for regulating medical devices. Medical devices are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. A medical device company must obtain FDA’s prior approval or clearance before marketing many medical devices in the United States. The Center for Devices and Radiological Health (CDRH) within FDA is primarily responsible for medical device review and regulation. CDRH activities are funded through a combination of appropriations from Congress and user fees collected from device manufacturers.

Congress first gave FDA the authority to collect user fees from medical device companies in the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). Congress reauthorized medical device user fees for five years (FY2013-FY2017) via the Medical Device User Fee Amendments of 2012 (MDUFA III, Title II of Food and Drug Administration Safety and Innovation Act, FDASIA, P.L. 112-144). The purpose of the user fee program is to reduce the time necessary to review and make decisions on medical product marketing applications. Lengthy review times affect the industry, which waits to market its products, and patients, who wait to use these products. The user fee law provides revenue for FDA. In exchange for the fees, FDA and industry negotiate performance goals for the premarket review of medical devices.

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review for moderate- and high-risk devices. There are two main paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies and submitting a premarket approval (PMA) application that includes evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be less costly and less time-consuming than the PMA path. Substantial equivalence is determined by comparing the performance characteristics of a new device with those of a predicate device. Demonstrating substantial equivalence does not usually require submitting clinical data demonstrating safety and effectiveness. In FY2015, FDA approved 98% of PMAs accepted for review and 85% of 510(k)s accepted for review were determined to be substantially equivalent.

On July 13, 2015, FDA held a public meeting on the reauthorization of the medical device user fee program. In September 2015 the agency began a series of negotiation sessions with industry on the reauthorization agreement as well as meetings with patient and consumer stakeholders on the status of the reauthorization process. If and when an agreement between FDA and industry is reached, the draft MDUFA IV package would likely consist of proposed statutory language and any agreement on FDA performance goals and procedures. The MDUFA IV draft agreement would be posted on the FDA website; after a public meeting and a 30-day comment period on the draft, a final MDUFA IV recommendation would be submitted to Congress.

Since medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA’s device budget. All user fees (as enacted) accounted for 43% of FDA’s total FY2016 program level. Medical device user fees accounted for 28% of the device and radiological health program level, which is $450 million in FY2016, including $107 million in medical device user fees and $20 million in other fees.

Over the years, concerns raised about user fees have prompted Congress to consider issues such as which agency activities could use the fees, how user fees can be kept from supplanting federal funding, and which companies should qualify as small businesses and pay a reduced fee.