TITLE

Company gets warning, drags out fixes

PUB. DATE
September 2008
SOURCE
Medical Device Daily;9/17/2008, Vol. 12 Issue 199, p2
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the warning letter sent by the U.S. Food and Drug Administration (FDA) to Fall Prevention Technologies, a maker of noncritical medical devices, which asked about a corrective action that the firm apparently indicated it will need until January 2009 to implement. According to the warning letter, the maker of the Balanceback iVNG, a diagnostic for assessing balance disorders, had not established an exhaustive quality system due to the absence of procedures for complaints, design controls and corrective and preventive actions.
ACCESSION #
34417038

 

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