Tuesday, June 22, 2010 12:21:20 PM
docmts2,
The following paragraph is from the FDA’s web site:
“About Advisory Committees
The Food and Drug Administration, to assist in its mission to protect and promote the public health, uses 49 committees and panels to obtain independent expert advice on scientific, technical, and policy matters.”
These committees DO NOT determine whether a new drug or device is SE or NSE.
Therefore, the fact that the radiological device advisory committee doesn't meet until July 21st should have no relevance to when the FDA will render its opinion on the DViS.
As others on this forum have noted, decisions on devices are made and issued by the FDA on a daily basis.
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