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Study: FDA Enforcement Growing for Medical Device Companies

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Speeding Time to Market at Motorola

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FDA Warns WebTrader Users: Remove Your Files or Lose Them

  • Read more about FDA Warns WebTrader Users: Remove Your Files or Lose Them
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A Jan.

A New Era in Food Safety Oversight

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Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate.

Global Cooperation Helps Expand Safety Net

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Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task.

FDA and EU Spar on Medical Device Regulation

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Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.

FDA Introduces Triage Pilot Program

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During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka

Medical Device CEO Laments ‘Anti-Industry’ FDA Culture

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While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over d

Going Long in Medical Device Manufacturing

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Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry.

Lawmakers’ Silly Season No Laughing Matter for Device Industry

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Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should ex

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