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recalls

William Hyman: FDA Database for Medical Device Recalls Falls Short

  • by AAMI
  • Posted on January 2, 2018January 2, 2018
  • Medical Device Industry

The FDA’s database for medical device recalls has a search function that includes a pull-down menu for the root cause of the recall. These root causes correspond to the single “FDA Determined Cause” on each […]

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Avinash Konkani: Improving Manufacturers’ Response Time in Correcting Problems

  • by AAMI
  • Posted on November 6, 2017
  • Healthcare Technology Management

As healthcare technology management (HTM) professionals, we understand how challenging it is to manage medical device recalls, perform field safety correction, and advise affected customers. All three of these notifications (i.e., recalls, field safety correction, […]

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William Hyman: Early (or Late) Warning with Medical Device Problems

  • by AAMI
  • Posted on January 7, 2016January 7, 2016
  • Medical Device Industry

Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For […]

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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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