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FDA Device Enforcement: An Analysis of Warning Letter Trends

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May 2012
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  • What one marketing mistake hit 10 devicemakers with warning letters in 2011?
  • Will recalls remain a key factor in triggering warnings to devicemakers in 2012?
  • If simply trending your quality data won’t prevent a warning letter — what will?

You’re far less of a target for warning letters and 483s when you have answers to questions like these. Here’s where to find them.

This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sights in the months ahead.

FDA Device Enforcement: An Analysis of Warning Letter Trends gives you access — and insights — into all device warning letters published in 2011. It maps out specific practices, policy glitches and omissions that triggered everything from quality and marketing citations to MDR reporting violations. Plus, the analysis goes a vital extra step to get you out in front of the FDA’s new target areas, including foreign supplier quality, data trending, medical device reporting and design controls.

Buy now for answers you need now to avoid warning letters down the road, including:

  • Which regulations are cited most often in today’s warning letters?
  • In what regions of the country are FDA device inspectors most active?
  • How do field office inspectors differ from those from Washington — and what do these differences mean to your company during an audit?
  • What warning letter findings are actually creating de facto guidance on topics such as risk analysis, purchasing controls and device safety?
  • And more

Remember, there are more audits than ever. If you’re targeted, you’ll be facing better-trained inspectors. Now is the time to get 100% clear about compliance hot spots and key actions that can protect you from costly warning letters.

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