• IEEE Trans Neural Syst Rehabil Eng · Sep 2007

    Review

    An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

    • Carlos Peña, Kristen Bowsher, Ann Costello, Robert De Luca, Sara Doll, Khan Li, Marie Schroeder, and Theodore Stevens.
    • Office of the Commissioner, U.S. Food and Drug Administration, Rockville, MD 20857, USA carlos.pena@fda.hhs.gov
    • IEEE Trans Neural Syst Rehabil Eng. 2007 Sep 1;15(3):421-4.

    AbstractThe United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review--from device classification and clinical studies to the final marketing application--FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…