Medical Device User Fee and Modernization Act of 2002
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Medical Device User Fee and Modernization Act of 2002 report (to accompany H.R. 3580). by United States. Congress. House. Committee on Energy and Commerce

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Published by U.S. G.P.O. in [Washington, D.C .
Written in English

Subjects:

  • United States. -- Food and Drug Administration.,
  • Medical laws and legislation -- United States.,
  • Medical instruments and apparatus -- Safety regulations -- United States.,
  • User charges -- United States.

Book details:

Edition Notes

SeriesReport / 107th Congress, 2d session, House of Representatives -- 107-728.
The Physical Object
Pagination73 p. ;
Number of Pages73
ID Numbers
Open LibraryOL17720103M

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Get this from a library! Medical Device User Fee and Modernization Act of [United States.]. Oct 9, H.R. (th). To amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. In , a database of bills in the U.S. Congress. Medical Device User Fee and Modernization Act of Medical Device User Fees Acts of & 3 Blue Book Memo - K – Medical Device User Fee and Modernization Act of (MDUFMA). Get this from a library! Medical Device User Fee and Modernization Act of report (to accompany H.R. ).. [United States. Congress. House. Committee on Energy and Commerce.].

  The Medical Device User Fee and Modernization Act of -- “MDUFMA” Overview of Key Provisions 1. 1 The Medical Device User Fee and Modernization Act of -- “MDUFMA” Overview of Key Provisions Michael A. Swit, Esq. Law Offices of Michael A. Swit [email protected] 2. The Food and Drug Administration (FDA) is announcing a public meeting to discuss our proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of (MDUFMA I) for fiscal years (FY) through , as well as other proposals to improve the review of medical devices and the third party inspection. FDA History and Definitions. History of FDA Laws and Acts. Chapter 1 and 2. STUDY. PLAY. Medical Device User Fee & Modernization Act • • Allowed for fees for PMA, Ks, and K supplementals • MDUFMA established the fees. Safe Medical Devices Act •   Congress first gave FDA the authority to collect user fees from medical device companies in the Medical Device User Fee and Modernization Act of (P.L. ). The purpose of the user fee program is to help reduce the time in which FDA can review and Author: Judith A. Johnson.

Subsequently, in October , section of the Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. ) further amended section of the FD&C Act by extending the requirement for electronic submission of registration information to include domestic firms as well as foreign firms. However, when adding these new electronic. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of , including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of /5(14). The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of , including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of 5/5(4). Mr. Heller also assisted the Advanced Medical Technology Association in obtaining further amendment of the Federal Food, Drug and Cosmetic Act's device provisions through the Medical Device User Fee and Modernization Act of and subsequent amendments.