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Medical Device User Fees And User Fee Acts
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Book Synopsis Medical Device User Fees and User Fee Acts by : Erin D. Williams
Download or read book Medical Device User Fees and User Fee Acts written by Erin D. Williams and published by . This book was released on 2010 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The FDA Medical Device User Fee Program by : Judith A. Johnson
Download or read book The FDA Medical Device User Fee Program written by Judith A. Johnson and published by Createspace Independent Pub. This book was released on 2012-07-06 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since April 24, 2012.) The Food and Drug Administration (FDA) is the agency responsible for the regulation of medical devices. These are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. A 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. 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). The purpose of the user fee program is to help reduce the time in which FDA can 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. The user fee law provides a revenue stream for FDA; in conjunction, the agency negotiates with industry to set performance goals for the premarket review of medical devices. Reauthorization of FDA's medical device user fees last occurred in 2007, just before the FDA's authority would expire, via the Medical Device User Fee Amendments of 2007 (MDUFA II). Current authority will expire on October 1, 2012. On February 1, 2012, FDA announced that it had reached “an agreement in principle” with the medical device industry on proposed recommendations for the second reauthorization—referred to as MDUFA III. A draft MDUFA III package, composed of statutory language and the FDA industry agreement on performance goals and procedures, was posted on the FDA website on March 14, 2012, and a public meeting describing the draft was held on March 28, 2012. The 30-day comment period on the draft ended April 16, 2012. Following review of the comments, FDA may revise the recommendation and then is to submit the final package to Congress. Since medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA's device budget. Medical device user fees have raised a number of concerns, prompting Congress to carefully consider issues such as which agency activities could use fees, how user fees can be kept from supplanting federal funding, and which companies should qualify as a small business and pay a reduced fee. Congress is also considering reauthorization of the Prescription Drug User Fee Act (PDUFA) as well as new proposals for a Generic Drug User Fee Act and a Biosimilars User Fee Act. It is likely that these three will be combined with MDUFA III along with a variety of related and unrelated issues.
Book Synopsis The FDA Medical Device User Fee Program by : Judith A. Johnson
Download or read book The FDA Medical Device User Fee Program written by Judith A. Johnson and published by . This book was released on 2013-01-07 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Admin. (FDA) is the agency responsible for the regulation of medical devices. These are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. A company must obtain FDA's prior approval or clearance before marketing many medical devices in the U.S. The Center for Devices and Radiological Health (CDRH) within FDA is primarily responsible for medical device review and regulation. 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 (MDUFA; P.L. 107-250). The purpose of the user fee program is to help reduce the time in which FDA can review and make decisions on marketing applications. Contents of this report: Introduction; Current Law; MDUFA Impact on FDA Review Time and Budget; MDUFA III Proposal. Figures and tables. This is a print on demand report.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :200 pages Book Rating :4.3/5 (121 download)
Book Synopsis Medical Device User Fees by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Download or read book Medical Device User Fees written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1994 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :24 pages Book Rating :4.:/5 (319 download)
Book Synopsis Medical Device User Fee Stabilization Act of 2005 by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Medical Device User Fee Stabilization Act of 2005 written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2005 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization by :
Download or read book Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unless Congress acts to reauthorize it, the Food and Drug Administration's (FDA's) authority to collect user fees under the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250) and, by reference, FDA's obligation to meet related performance goals, will expire on October 1, 2007. According to the President's budget request, in FY2008, funds from a reauthorized MDUFMA would account for an estimated $47.5 million and 200 full-time equivalent employees (FTEs). This would comprise 16.6% of FDA's medical device review budget authority and 13.0% of its medical device review-related FTEs. While these numbers and percentages are not as high as those projected for collection under a similar FDA user fee authority related to prescription drugs (pursuant to the Prescription Drug User Fee Act), they are significant. For MDUFMA as passed in 2002 ("MDUFMA I"), the fee amounts and performance goals articulated and incorporated in statute were the result of an agreement between FDA and the medical device industry. In order to facilitate the reauthorization of MDUFMA ("MDUFMA II") in April 2007, the FDA and industry published the results of their negotiations with a notice of an April 30, 2007, public meeting on the topic. According to FDA, during the five years covered by the proposals (through 2012), FDA would receive approximately $287 million from user fees. This represents an increase from the $110 million FDA received during the first four years of the program. The industry agreement also calls for changes in the fee structure, performance goals, small business relief, and third party inspection program. In addition, the agreement reflects FDA's initiatives related to the regulation of in vitro diagnostic devices (laboratory tests). (MDUFMA I enabled third party inspections and set standards for the use of reprocessed single-use devices.) The details of the proposed MDUFMA II provisions have been incorporated into Senator Kennedy's bill, the Food and Drug Administration Revitalization Act as reported out of the Senate Health, Education, Labor, and Pensions Committee (S. 1082). The details of MDUFMA I and these proposals for MDUFMA II are discussed in this report, following an introduction to FDA's medical device review process. This report will be updated as needed.
Book Synopsis Food and Drug Administration by : Randall B. Williamson
Download or read book Food and Drug Administration written by Randall B. Williamson and published by DIANE Publishing. This book was released on 2007-08 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food & Drug Amin. (FDA) is responsible for approving medical devices -- such as catheters & artificial hearts -- to provide reasonable assurance of their safety & effectiveness. Congress enacted the Medical Device User Fee & Modernization Act of 2002 (MDUFMA) which authorizes FDA to charge user fees for some device applications & not others. In FY2005, FDA collected $31 million in user fees from device applications. This report provides revenue information for: (1) companies that qualified as small businesses under the MDUFMA user fee program in FY2006; & (2) companies publicly traded in the U.S. that submitted device applications subject to user fees & did not qualify as small businesses under MDUFMA in FY2006. Charts.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :160 pages Book Rating :4.0/5 ( download)
Book Synopsis Reauthorization of the Medical Device User Fee and Modernization Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of the Medical Device User Fee and Modernization Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :320 pages Book Rating :4.0/5 ( download)
Book Synopsis Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis User Fee Programs for Medical Products at the Food and Drug Administration by :
Download or read book User Fee Programs for Medical Products at the Food and Drug Administration written by and published by . This book was released on with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 18 GAO Analysis-Impact of User Fees: Budget Details, Federal Government, HHS, and FDA Funding, Fiscal Year 2008 19 GAO Analysis-Impact of User Fees: Budget Details • In 2009, GAO reported that total funding for medical product programs increased from about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year 2008. [...] 22 GAO Analysis-Impact of User Fees: Budget Details, Portion of Total Medical Product Program Funding Allocated to User Fees Activities and Other Program Activities, Fiscal Years 1999 and 2008 23 GAO Analysis-Impact of User Fees: Staffing Details • Staffing resources for FDA's medical product programs increased between fiscal year 1999 and fiscal year 2008. [...] • The number of medical product program FTEs funded by user fees increased 113 percent-from 856 FTEs in fiscal year 1999 to 1,825 FTEs in fiscal year 2008-while FTEs funded by fiscal year appropriations declined 7 percent, or from 4,069 FTEs in fiscal year 1999 to 3,802 FTEs in fiscal year 2008. [...] 31 GAO Analysis-Impact of User Fees on Non-User Fee Activities: Examination of Advertising and Promotional Materials • Funding for FDA's oversight of drug advertising and promotion increased 167 percent from about $4 million in fiscal year 2004 to about $10 million in fiscal year 2008. [...] 20548 202-512-3407 [email protected] User Fee Programs for Medical Products at the Food and Drug Administration Introduction Drug Application Review Times Before User Fees Prescription Drug User Fee Act (PDUFA) Drug Application Review Times Following the Enactment of User Fees Medical Device Review Times Before User Fees Medical Device Review Times Before User Fees Medical Device User Fee and Modern.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :224 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA User Fees 2012 by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book FDA User Fees 2012 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2013 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device User Fee and Modernization Act of 2002 by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Medical Device User Fee and Modernization Act of 2002 written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2002 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Food and Drug Administration Safety and Innovation Act by : James C. Perry
Download or read book The Food and Drug Administration Safety and Innovation Act written by James C. Perry and published by Nova Science Publishers. This book was released on 2014-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration Safety and Innovation Act (FDASIA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorisation act, FDASIA does include four titles relating to user fees. This book focuses on these acts, as well as the prescription drug user fee act, the FDA medical device user fee program and discusses the proposed FDA user fee acts generic drug user fee amendments.
Book Synopsis FDA Regulation of Medical Devices by : Judith A. Johnson
Download or read book FDA Regulation of Medical Devices written by Judith A. Johnson and published by CreateSpace. This book was released on 2012-07-06 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since December 28, 2011.) Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system. In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products, including devices. FDA's Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers) which together comprise FDA's total. User fees account for 33% of FDA's total FY2011 program level and 15% of CDRH's program level, which is $378 million in FY2011 including $56 million in user fees. FDA's authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85). FDA requires all medical product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires 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 much less expensive and less time- consuming than seeking FDA approval via PMA.
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781983923746 Total Pages :318 pages Book Rating :4.9/5 (237 download)
Book Synopsis Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation by : United States. Congress
Download or read book Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-17 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discussion drafts concerning Prescription Drug User Fee Act reauthorization, Medical Device User Fee and Modernization Act reauthorization, drug safety, and certain pediatric pharmaceutical and device legislation : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, Jun
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Medical Devices and the FDA by : Gil Frazier
Download or read book Medical Devices and the FDA written by Gil Frazier and published by Nova Science Pub Incorporated. This book was released on 2012-12-20 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices. They may be simple tools used during medical examinations, such as tongue depressors and thermometers, or high-tech life-saving implants like heart valves and coronary stents. The medical device market has been characterized as including eight industry sectors: surgical and medical instrument manufacturing, surgical appliance and supplies, in vitro diagnostic products (IVDs, or laboratory tests), electromedical and electrotherapeutic apparatus, irradiation apparatus, dental equipment and supplies, ophthalmic goods, and dental laboratories. This book explores FDA regulation of medical devices with a focus on the user fee program and tort claims.