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Compliance In Focus
Posted by John Lehmann on Mon, Jan 30, 2012

What’s on the FDA's "To Do" List for Devices in 2012?

The FDA released its four main priorities for 2012, and the focus of the FDA will be:

  1. Fully implement a total product life cycle approach by enhancing and integrating the premarket, postmarket, and compliance information and functions. 
  2. Enhance communication and transparency with stakeholders, internal communications, and supporting two-way communication. 
  3. Strengthen workforce and workplace with efficient administration of CDRH programs. 
  4. Proactively facilitate innovation to address unmet public health needs to facilitate the development of innovative, safe and effective medical devices and advance regulatory science.

That’s quite a tall order for the upcoming year! However, the FDA did have a productive year in 2011, and plans to continue and completing the work started in the four priority areas. Some of the FDA’s highlights in 2011 include:

MassDevice recently released an article on the FDA’s 2012 goals as well, emphasizing the FDA’s strategic priorities “including final versions of all guidance documents, guidelines for acceptable clinical data from foreign countries, streamlining the recall process and creating a framework for post-market surveillance.” The article also references the watchdog’s agency’s Center for Devices & Radiological Health plans to concentrate on fully implementing a "total product life cycle approach," enhance its internal and external communication and transparency, strengthen its workforce, and "proactively facilitate innovation."

What goals would you like to see the FDA achieve this year for the Medical Device Industry? Would you add anything to the “To Do” list?

Topics: Medical Devices, john lehmann, FDA


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