Medical Device User Fees
DOWNLOAD
Download Medical Device User Fees PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Medical Device User Fees book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
The Fda Medical Device User Fee Program
DOWNLOAD
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
DOWNLOAD
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.
Medical Device User Fees And User Fee Acts
DOWNLOAD
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.
Medical Device User Fees
DOWNLOAD
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.
Food And Drug Administration
DOWNLOAD
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.
The Fda Medical Device User Fee Program
DOWNLOAD
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.
Reauthorization Of The Medical Device User Fee And Modernization Act
DOWNLOAD
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
language : en
Publisher:
Release Date : 2008
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 has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Law categories.
Medical Device User Fees And User Fee Acts
DOWNLOAD
Author :
language : en
Publisher:
Release Date : 2008
Medical Device User Fees And User Fee Acts written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.
The Fda Medical Device User Fee Program
DOWNLOAD
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.
Medical Devices And The Fda
DOWNLOAD
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.