{ "id": "R44517", "type": "CRS Report", "typeId": "REPORTS", "number": "R44517", "active": true, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 586723, "date": "2017-03-03", "retrieved": "2020-01-02T14:46:36.594181", "title": "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\u2019s 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.\nCongress 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. \nThe 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.\nIn 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. \nSince 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\u2019s 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.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R44517", "sha1": "ca78e0aaa85d9fc77113461aefc96a6b61febb0d", "filename": "files/20170303_R44517_ca78e0aaa85d9fc77113461aefc96a6b61febb0d.html", "images": { "/products/Getimages/?directory=R/html/R44517_files&id=/2.png": "files/20170303_R44517_images_13015f571128571092ad4927cdcb178a41618d72.png", "/products/Getimages/?directory=R/html/R44517_files&id=/3.png": "files/20170303_R44517_images_018e106dcfa6d0ebb75a96ab4d6f70099e9beee7.png", "/products/Getimages/?directory=R/html/R44517_files&id=/4.png": "files/20170303_R44517_images_9597dfcc02d1461a5222da8530336e4089d2caa6.png", "/products/Getimages/?directory=R/html/R44517_files&id=/1.png": "files/20170303_R44517_images_00b76924a9ba12183ed919e969fe5c5d9826571c.png", "/products/Getimages/?directory=R/html/R44517_files&id=/0.png": "files/20170303_R44517_images_b24e24d7f3b64eecb26294487cae01a15e2de7ee.png" } }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R44517", "sha1": "6db86808d229df9a970e7fd7f8df0c789c4a993a", "filename": "files/20170303_R44517_6db86808d229df9a970e7fd7f8df0c789c4a993a.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 455530, "date": "2016-09-02", "retrieved": "2016-09-09T18:32:39.839199", "title": "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\u2019s 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.\nCongress 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 most recently 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. Under MDUFA III, FDA was authorized to collect $595 million from industry over FY2013 through FY2017. In exchange for the fees, FDA and industry negotiate performance goals for the premarket review of medical devices. \nThe 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.\nIn 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. When released, the draft MDUFA IV package will be posted on the FDA website and will likely consist of proposed statutory language and an agreement on FDA performance goals and procedures. The law next requires a public meeting, a 30-day comment period, and that the final MDUFA IV recommendation be submitted to Congress in January 2017.\nSince medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA\u2019s device budget. All user fees (as enacted) accounted for 43% of FDA\u2019s 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.\nOver 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.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44517", "sha1": "9a3d79bab982e4a1904a14ac53a67679858e48f8", "filename": "files/20160902_R44517_9a3d79bab982e4a1904a14ac53a67679858e48f8.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44517", "sha1": "1de80b02138e7db36c238b6d8bba963bd9969632", "filename": "files/20160902_R44517_1de80b02138e7db36c238b6d8bba963bd9969632.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 2678, "name": "Medical Product Regulation" } ] }, { "source": "EveryCRSReport.com", "id": 453164, "date": "2016-06-06", "retrieved": "2016-06-21T21:07:56.632819", "title": "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\u2019s 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.\nCongress 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. \nThe 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.\nOn 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.\nSince medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA\u2019s device budget. All user fees (as enacted) accounted for 43% of FDA\u2019s 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.\nOver 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.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R44517", "sha1": "41b446d001011963bc1eeec6270a6c0849167bbf", "filename": "files/20160606_R44517_41b446d001011963bc1eeec6270a6c0849167bbf.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R44517", "sha1": "e43907a7f5695cb12f0766d42f9c7943e18cafd2", "filename": "files/20160606_R44517_e43907a7f5695cb12f0766d42f9c7943e18cafd2.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 2678, "name": "Medical Product Regulation" } ] } ], "topics": [ "Appropriations" ] }