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Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: manufacturing, foreign, establishments, congressional, testimony, inspections, conducting, devices, fda, faces, challenges, medical
Number of Pages: 26
Published: 2008-12
ISBN-10: 1437905277
ISBN-13: 9781437905274

As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDAżs program for inspecting foreign establishments that manufacture medical devices for the U.S. market; an
17566

Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: inspections, congressional, testimony, manufacturer, conducting, devices, challenges, fda, medical
Number of Pages: 30
Published: 2008-05-01
ISBN-10: 1437900208
ISBN-13: 9781437900200

As part of the FDAżs oversight of the safety & effectiveness of medical devices marketed in the U.S., it inspects domestic & foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee & Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. This statement: (1) assesses FDAżs mgmt. of inspections of establishments -- particularly those in foreign countries -- manufacturing devices for the U.S. marke
8336

Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: drug, fda, foreign, inspection, program, strengthen, needed, safety, data, management, inspections
Number of Pages: 58
Published: 2009-05
ISBN-10: 1437911307
ISBN-13: 9781437911305

The FDA oversees the safety and effectiveness of human drugs marketed in the U.S., including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines: (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection; (2) the frequency of foreign inspections; and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. The author analyzed info. from FDA d
10252

Authors: John Mendeloff, Christopher Nelson, Kilkon Ko, Am
Publisher: RAND
Keywords: exploratory, analysis, risk, fatality, businesses, workplace, small
Number of Pages: 100
Published: 2006
ISBN-10: 083303944X
ISBN-13: 9780833039446

Over 55 percent of Americans are employed in businesses with fewer than 100 workers. Policymakers have taken action to lessen regulatory burden on small business. However, evidence shows that small establishments-single physical locations-have much higher rates of deaths or serious injuries than do larger establishments. This study examined the relationship between fatality rate and business size, both in terms of establishment size and firm size, from 1992 to 2001. The analysis uses fatality data drawn from Occupational Safety and Health Administration (OSHA) accident investigation reports an
427

Author: DIANE Publishing Company
Publisher: DIANE Publishing
Keywords: private, establishments, large, medium, benefits, employee
Number of Pages: 179
Published: 1995-08
ISBN-10: 0788121286
ISBN-13: 9780788121289

Presents results of a survey of the incidence & detailed provisions of selected employee benefit plans in medium & large private establishments, such as: work schedules, disability benefits, medical care, life insurance, & more. Provides representative data for 34 million employees in the Nation's private nonagricultural industries. Over 200 tables.
55121

Author: DIANE Publishing Company
Publisher: DIANE Publishing
Keywords: private, establishments, large, medium, benefits, employee
Number of Pages: 150
Published: 1994-05-01
ISBN-10: 078810814X
ISBN-13: 9780788108143

The results of a large-scale survey that dealt with the incidence & detailed provisions of selected employee benefit plans in medium & large private establishments. Provides representative data for 36 million employees in private nonagricultural industries in the U.S. Covers both full- & part-time employees. Includes: parental leave, disability benefits, medical care, life insurance, pension plans, & much more. Over 120 statistical tables.
29861

Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: device, inspections, manufacturing, establishments, testimony, congressional, surveillance, postmarket, shortcomings, devices, fda, premarket, review, medical
Number of Pages: 22
Published: 2010-05
ISBN-10: 1437918212
ISBN-13: 9781437918212

Americans depend on FDA to provide assurance that medical devices (MD) sold in the U.S. are safe and effective. FDA classifies MD types into 3 classes, with class I: those with the lowest risk to patients (such as forceps) and class III: those with the greatest risk (such as pacemakers). FDA's responsibilities include premarket and postmarket oversight -- spanning, for ex., both premarket review of MD and postmarket surveillance. These responsibilities apply to all devices marketed in the U.S., regardless of whether they are manufactured domestically or overseas. This testimony relates to FDA'
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