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Compliance In Focus
Posted by John Lehmann on Fri, Sep 7, 2012

FDA: Is a Better Postmarketing Surveillance System Needed?

Medical Device Postmarketing SurveillanceResulting from performance concerns of many devices, questions have surfaced on whether the current postmarket surveillance system is “optimally structured to meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology.” This was noted in a recent release in the Federal Register which also announced the public meeting being held by FDA to examine the issue of postmarket surveillance.

FDA is hosting a public meeting, “Strengthening the National Medical Device Postmarket Surveillance System” to gain feedback on the proposal to strengthen the surveillance system.  The topics up for discussion at the meeting include:

• The unique device identifier system and its incorporation into health-related electronic records;
• National and international device registries for selected products;
• Adverse event reporting and analysis; and
• Developing and using new methods for evidence generation synthesis and appraisal.

The goal of FDA is to develop and implement a comprehensive system that will include strategies for collection, analyzing, and acting on medical device postmarket information. Specifically the FDA hopes to gain the public’s feedback on key questions like:

  • Are these the right efforts?
  • What principles should drive these efforts?
  • What are the attributes of an effective “active surveillance” system for devices?
  • How can the device active surveillance system leverage existing systems?

If you were attending the meeting, what comments would you give? Share below!

Photo Credit: theunquietlibrarian

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Topics: Postmarketing Surveillance System, Federal Register, FDA


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