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Food and Drug Administration

William Hyman: The Mystery of ‘Updated’ FDA Web Pages

  • by AAMI
  • Posted on April 21, 2016April 21, 2016
  • Medical Device Industry

In the lower left-hand corner of most FDA web pages is a date given as “page last updated.” The straightforward understanding of this would be that either the whole page or something substantive on the […]

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William Hyman: Another Visit to the FDA’s Action Plan

  • by AAMI
  • Posted on January 5, 2015January 5, 2015
  • Healthcare Technology Management

In a January 2014 blog post, I reported on a third visit to the FDA’s own scorecard for its 2013 Action Plan. As of Jan. 1, 2015, this page showed a last updated date of […]

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William Hyman: Updated, but Not Up To Date at the FDA

  • by AAMI
  • Posted on November 7, 2014November 7, 2014
  • Regulations

A challenge in the fast-moving medical device industry is the maintenance of up-to-date information. The U.S. Food and Drug Administration (FDA) faces this challenge in keeping its various online resources current and consistent. While FDA […]

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William Hyman: The FDA’s Self-Imposed Deadlines (Part III)

  • by AAMI
  • Posted on January 6, 2014
  • Healthcare IT

In July 2013 and October 2013, I addressed the U.S. Food and Drug Administration’s progress in completing the various elements of improvements to its postmarket surveillance program. This effort has 14 parts divided among three […]

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William Hyman: The FDA’s Self-Imposed Deadlines (Part II)

  • by AAMI
  • Posted on October 25, 2013
  • Regulations

Back in July, I wrote about the first deadline that the U.S. Food and Drug Administration had set for itself with respect to a series of activities to improve its postmarket surveillance system. Of the […]

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Leighton Hansel: Despite Criticism, U.S. Regulation of Medical Devices Is a Success

  • by AAMI
  • Posted on May 28, 2013May 28, 2013
  • Regulations

In recent years, the FDA’s premarket notification process has been challenged as an ineffective tool for assuring that safe and effective devices enter the marketplace. That criticism, however, is too broad and fails to recognize […]

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