Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments

PDF Version Also Available for Download.

Description

Testimony issued by the Government Accountability Office with an abstract that begins "Americans depend on the Food and Drug Administration (FDA) to provide assurance that medical devices sold in the United States are safe and effective. FDA classifies medical device types into three classes, with class I including those with the lowest risk to patients (such as forceps) and class III including those with the greatest risk (such as pacemakers). FDA's responsibilities include premarket and postmarket oversight--spanning, for example, both premarket review of devices and postmarket surveillance (the collection and analysis of data on marketed devices). These responsibilities apply to ... continued below

Creation Information

United States. Government Accountability Office. June 18, 2009.

Context

This text is part of the collection entitled: Government Accountability Office Reports and was provided by UNT Libraries Government Documents Department to Digital Library, a digital repository hosted by the UNT Libraries. More information about this text can be viewed below.

Who

People and organizations associated with either the creation of this text or its content.

Provided By

UNT Libraries Government Documents Department

Serving as both a federal and a state depository library, the UNT Libraries Government Documents Department maintains millions of items in a variety of formats. The department is a member of the FDLP Content Partnerships Program and an Affiliated Archive of the National Archives.

Contact Us

What

Descriptive information to help identify this text. Follow the links below to find similar items on the Digital Library.

Description

Testimony issued by the Government Accountability Office with an abstract that begins "Americans depend on the Food and Drug Administration (FDA) to provide assurance that medical devices sold in the United States are safe and effective. FDA classifies medical device types into three classes, with class I including those with the lowest risk to patients (such as forceps) and class III including those with the greatest risk (such as pacemakers). FDA's responsibilities include premarket and postmarket oversight--spanning, for example, both premarket review of devices and postmarket surveillance (the collection and analysis of data on marketed devices). These responsibilities apply to all devices marketed in the United States, regardless of whether they are manufactured domestically or overseas. In 2009, GAO added FDA's oversight of medical products, including devices, to its list of high-risk areas warranting attention by Congress and the executive branch. GAO was asked to testify on recent work related to FDA's responsibilities for medical devices, including premarket review, postmarket surveillance, and inspection of manufacturing establishments. This statement is based on a recent GAO report, Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process (GAO-09-190, January 15, 2009) and on other GAO reports and testimonies related to FDA oversight."

Language

Item Type

Identifier

Unique identifying numbers for this text in the Digital Library or other systems.

Collections

This text is part of the following collection of related materials.

Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

What responsibilities do I have when using this text?

When

Dates and time periods associated with this text.

Creation Date

  • June 18, 2009

Added to The UNT Digital Library

  • June 11, 2014, 5:03 a.m.

Usage Statistics

When was this text last used?

Yesterday: 0
Past 30 days: 0
Total Uses: 6

Where

Geographical information about where this text originated or about its content.

Place Name

Publication Place

Map Information

  • map marker Automatically generated Place Name coordinates.
  • map marker Automatically generated Publication Place coordinates.
  • Repositioning map may be required for optimal printing.

Mapped Locations

Interact With This Text

Here are some suggestions for what to do next.

Start Reading

PDF Version Also Available for Download.

Citations, Rights, Re-Use

United States. Government Accountability Office. Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments, text, June 18, 2009; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc293999/: accessed December 12, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.