The Fda Medical Device User Fee Program
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The Fda Medical Device User Fee Program
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Author : Judith A. Johnson
language : en
Publisher:
Release Date : 2013-01-07
The Fda Medical Device User Fee Program written by Judith A. Johnson and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-01-07 with categories.
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.
The Fda Medical Device User Fee Program
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Author : Judith A. Johnson
language : en
Publisher: Createspace Independent Pub
Release Date : 2012-07-06
The Fda Medical Device User Fee Program written by Judith A. Johnson and has been published by Createspace Independent Pub this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-06 with Medical categories.
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.
The Fda Medical Device User Fee Program
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Author : Judith Ann Johnson
language : en
Publisher:
Release Date : 2016
The Fda Medical Device User Fee Program written by Judith Ann Johnson and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Medical instruments and apparatus categories.
The Fda Medical Device User Fee Program
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Author :
language : en
Publisher:
Release Date : 2012
The Fda Medical Device User Fee Program written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with categories.
Food And Drug Administration
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Author : Randall B. Williamson
language : en
Publisher: DIANE Publishing
Release Date : 2007-08
Food And Drug Administration written by Randall B. Williamson and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-08 with categories.
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.
Medical Device User Fees
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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
language : en
Publisher:
Release Date : 1994
Medical Device User Fees written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Law categories.
Fda Regulation Of Medical Devices
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Author : Judith A. Johnson
language : en
Publisher: CreateSpace
Release Date : 2012-07-06
Fda Regulation Of Medical Devices written by Judith A. Johnson and has been published by CreateSpace this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-06 with Medical categories.
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.
Medical Device User Fees And User Fee Acts
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Author : Erin D. Williams
language : en
Publisher:
Release Date : 2010
Medical Device User Fees And User Fee Acts written by Erin D. Williams and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical instruments and apparatus industry categories.
User Fee Programs For Medical Products At The Food And Drug Administration
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Author :
language : en
Publisher:
Release Date :
User Fee Programs For Medical Products At The Food And Drug Administration written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
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.
Medical Devices And The Fda
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Author : Gil Frazier
language : en
Publisher: Nova Science Pub Incorporated
Release Date : 2012-12-20
Medical Devices And The Fda written by Gil Frazier and has been published by Nova Science Pub Incorporated this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-20 with Law categories.
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.