	Introduction

In 2002, the Medical Device User Fee and Modernization Act (MDUFMA, also called MDUFA I) gave the Food and Drug Administration (FDA) the authority to collect fees from the medical device industry. User fees and annual discretionary appropriations from Congress fund the review of medical devices by the FDA. Medical devices are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. Manufacturers of moderate and high risk medical devices must obtain FDA approval or clearance before marketing their device in the United States. The Center for Devices and Radiological Health (CDRH) has primary responsibility within FDA for medical device premarket review. The primary purpose of user fees is to support the FDA's medical device premarket review program and to help reduce the time it takes the agency to review and make decisions on marketing applications. Lengthy review times affect the industry, which waits to market its products, and patients, who wait to use these products. In exchange for the fees, FDA and industry negotiate performance goals for the premarket review of medical devices. FDA's medical device user fee authorities were last reauthorized through September 30, 2017, by the Medical Device User Fee Amendments of 2012 (MDUFA III). MDUFA III was enacted as Title II of Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. Of the unique devices that are listed by manufacturers with FDA in FY2016, about 63% were exempt from premarket review; the remainder entered the market via the 510(k) process (35%), the premarket approval (PMA) process (1%), or via other means, such as the humanitarian device exemption (see " FDA Premarket Review of Medical Devices " and " Exemptions and Discounted Fees "). In general, for moderate-risk and high-risk medical devices, there are two pathways that manufacturers can use to bring such devices to market with FDA's permission. One pathway consists of conducting clinical studies, then submitting a premarket approval (PMA) application with evidence providing reasonable assurance that the device is safe and effective. With the 510(k), the manufacturer demonstrates that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. Substantial equivalence is determined by comparing the performance characteristics of a new device with those of a predicate device. According to FDA data, 85% of 510(k)s accepted for review in FY2015 were determined to be substantially equivalent. The total fees authorized to be collected over the five-year period FY2013 through FY2017 is $595 million. MDUFA Impact on Total Review Time and FDA/CDRH Budget

The amount of time it takes FDA to reach a review decision to clear a 510(k) notification or approve a PMA application is a measure of how well the agency is meeting the goals defined in the MDUFA agreement between FDA and the medical device industry. All user fees (as enacted) account for 42% of FDA's total FY2016 program level. User fees are an increasing proportion of FDA's device-related budget. In FY2005, medical device user fees accounted for 15% of the MDUFA program total costs, compared with 35% in FY2015 as shown in Figure 4 and Table 2 . On August 22, 2016, FDA announced that it had reached an agreement in principle with the medical device industry and laboratory community on proposed recommendations for the reauthorization of the medical device user fee program. Under the draft agreement, FDA would be authorized to collect $999.5 million in user fees plus inflation adjustments over the five-year period, FY2018 through FY2022. A public meeting to discuss the recommendations for reauthorization of MDUFA was held on November 2, 2016; materials from this meeting are posted on FDA's website.
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 annual discretionary 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 last reauthorized medical device user fees for a five-year period (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 primary 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. Under MDUFA III, FDA was authorized to collect $595 million from industry from FY2013 through FY2017. In exchange for the fees, FDA and industry negotiated 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 95% of PMAs accepted for review and 85% of 510(k)s accepted for review were determined to be substantially equivalent.
In September 2015, the agency began a series of negotiation sessions with industry on the MDUFA IV reauthorization agreement. On August 22, 2016, FDA announced it had reached an agreement in principle with industry on proposed recommendations for the reauthorization. Under the draft agreement, FDA would be authorized to collect $999.5 million in user fees plus inflation adjustments over the five-year period starting in October 2017. The MDUFA IV draft and final commitment letters and proposed statutory changes are posted on the FDA website. A public meeting to discuss the proposed recommendations for reauthorization of MDUFA was held on November 2, 2016, and the final agreement between agency and industry has been submitted to Congress.
Since medical device user fees were first collected in FY2003, they have comprised an increasing proportion of the MDUFA program. In FY2006, medical device user fees accounted for 16% of the MDUFA program total costs, compared with 35% in FY2015. All user fees (as enacted) accounted for 42% of FDA's total FY2016 program level. 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.