Food and Drug Administration (FDA) review of medical products (human drugs and devices) is funded through a combination of annual discretionary appropriations from Congress (budget authority) and user fees collected from industry. The human medical product user fee programs require reauthorization every five years to continue uninterrupted. Prior to the passage of the Food and Drug Administration Reauthorization Act of 2017 (FDARA, P.L. 115-52 ), these programs were set to expire on September 30, 2017. The reauthorization legislation typically includes additional provisions related to FDA, since for many the bill is considered "must-pass" legislation in order for FDA product review activities to continue uninterrupted; as in prior reauthorizations, Congress made this user fee legislation a vehicle for addressing other FDA-related issues. FDARA continues the five-year reauthorization cycle of the human medical product user fee programs, which allows FDA to continue collecting fees and using the revenue to support, among other things, the review of marketing applications for brand-name and generic drugs, biological and biosimilar products, and medical devices. In addition to titles that reauthorize the drug, device, generic drug, and biosimilar biological product user fee programs through FY2022, FDARA includes titles that modify the drug and device regulatory processes to encourage the development of drugs and devices for pediatric use; amend the law regarding medical device, prescription drug, and generic drug regulation; and make changes in several cross-cutting areas, such as annual reporting on inspection and analysis of use of funds. The passage of the 21 st Century Cures Act ( P.L. 114-255 ) in December 2016 resulted in numerous changes to the FDA approval processes for drugs, devices, and biologics, as well as other reforms to FDA. Therefore, fewer non-user fee provisions were included in FDARA. FDARA has nine titles, as listed in Table 1 . Titles I through IV authorize FDA to collect fees and use the revenue to support specified activities for the review of prescription brand-name drugs and biological products, medical devices, generic drugs, and biosimilar biological products. Title V makes modifications to facilitate the development and approval of drugs and devices for pediatric populations. Title VI addresses various aspects of prescription drug regulation, including drug supply chain security and expanded access, among other topics. Title VII makes modifications to the device inspection and approval processes. Title VIII makes modifications to improve patient access to generic drugs. Finally, Title IX covers annual reporting on inspections, performance reporting requirements, and analysis of use of funds, among other topics. This report presents an overview of FDARA by title and section, providing a narrative context for each title, as well as a brief description of each section. There is generally one bullet for each section, and the FDARA section number is listed after the bullet in parentheses. For lengthy sections with multiple subsections, the FDARA section number and subsection are listed after the bullet in parentheses. Where relevant, the Federal Food, Drug, and Cosmetic Act (FFDCA) section being amended by the FDARA section is noted either in the introductory text or in the bulleted text. FDARA reauthorizes the prescription drug user program for another five years, from FY2018 through FY2022. With the Prescription Drug User Fee Act (PDUFA) in 1992, Congress authorized FDA to collect user fees from the manufacturers of brand-name prescription drugs and biological products and to use the revenue for specified activities. For PDUFA to succeed, FDA, industry, and Congress had to agree on two concepts: (1) performance goals —FDA would commit to performance goals it would negotiate with industry that set target completion times for various review processes; and (2) use of fees —the revenue from prescription drug user fees would be used only for activities to support the review of human drug applications and would supplement, rather than replace, funding that Congress appropriated to FDA. The added resources from user fees allowed FDA to increase staff to review what was then a backlog of new drug applications and to reduce application review times. Over the years, Congress has added similar authority regarding the regulatory review of other medical products. User fees made up 41% of the FY2017 FDA budget. , Following the precedent set by PDUFA, the user fee programs addressed in this legislation include both (1) legislation and (2) performance goal agreements developed with representatives of the regulated industry in consultation with representatives of patients and advocates, academic and scientific experts, and congressional committees. FDA may use the revenue from PDUFA fees to support "the process for the review of human drug applications." Congress has used the reauthorization process to expand the range of activities included in that phrase. The prescription drug user fee program covers new drugs whose sponsors are the first to apply for marketing approval (excluding, therefore, generic drugs) and new biological products (excluding, therefore, the newer category of biosimilar biological products). Each five-year reauthorization sets a total amount of fee revenue for the first year and provides a formula for annual adjustments to that total based on inflation and workload changes. Until now (PDUFA I through V), PDUFA had required that three types of fees each contribute one-third of the fee revenue every year: application fees, establishment fees, and product fees. In general, FDARA Title I, the Prescription Drug User Fee Amendments of 2017 (commonly referred to as PDUFA VI), makes the following amendments to FFDCA Sections 736 and 736B: Establishes a new user fee structure to include a program fee , eliminating the establishment and product fees from earlier versions of PDUFA; continues the application fee , while eliminating the fee for a supplemental application (§102(a)). Provides that of the total prescription drug user fee revenue to be collected each year, 80% is to come from program fees and 20% is to come from application fee ; establishes the annual base revenue and specifies additional dollar amounts for each of FY2018 through FY2022 (§102(b)). Modifies the inflation adjustment calculation; replaces the workload adjustment with a capacity planning adjuster; eliminates the final year adjustment provisions; establishes an annual operating reserve adjustment; and establishes an additional direct cost adjustment (§102(c)). Continues the requirement that the Secretary of Health and Human Services (HHS) establish and publish fees before the start of each fiscal year (§102(c)). Continues to require the Secretary to waive or reduce a fee (1) to protect the public health, if the fee would present a significant barrier to innovation, or (2) for the first human drug application from a small business; eliminates the authority of the Secretary to waive or reduce a fee because the fee would exceed the anticipated present and future costs of the review (§102(d)). Continues to consider an application or supplemental application to be incomplete until all required fees (now the application and program fees) have been paid (§102(e)). To ensure that user fees supplement rather than replace congressional appropriations, continues the requirements, referred to as "triggers," that FDA may collect and use fees only if, for each year, (1) FDA spends at least as much from direct appropriations for the review of human drug applications as it had in FY1997 (adjusted for inflation), and (2) appropriations (excluding fees) for FDA salaries and expenses, overall, are equal to or greater than the appropriations (excluding fees and adjusted for inflation) for FY1997 (§102(f)). Continues to allow for the early payment of authorized fees (§102(g)). Continues the requirement for annual performance and fiscal reports (§103). Authorizes these prescription drug user fees from October 1, 2017, through September 30, 2022 (§§104 and 105). Includes a savings clause noting that fees for applications accepted by FDA for filing on or after October 1, 2012, but before October 1, 2017, will remain as under prior law (§106). Medical devices include a wide range of products used to diagnose, treat, monitor, or prevent a disease or condition in a patient. For many medical devices, FDA approval or clearance must be obtained prior to marketing them in the United States. Congress gave FDA the authority to collect fees from the medical device industry in 2002. User fees and direct appropriations from Congress fund FDA's review of medical devices. The user fees support FDA's medical device premarket review program to help reduce the time it takes the agency to review and decide on marketing applications. The medical device user fee program was modeled after the PDUFA program. It provides revenue for FDA; in conjunction, the agency negotiates with industry to set performance goals for the premarket review of medical devices. In general, Title II, the Medical Device User Fee Amendments of 2017 (MDUFA), makes the following amendments to FFDCA Sections 738 or 738A (titles that amend a different FFDCA section are noted): Adds a definition for the term "de novo classification request" (§202). Changes the fee for a premarket notification submission, also called a 510(k) submission, from 2.0% of the premarket application (PMA) fee to 3.4% of the PMA fee; adds a new fee for a de novo classification request equal to 30% of the PMA fee; adds that no fee would be required for a de novo classification request if the device is intended solely for a pediatric population (§203(a)).