Rosenberg is responding to Rice's letter from December 22nd, regarding the Mental Health Law Project's role in the FDA reclassification proceeding held on November 4th. Rosenberg provides the background of the Project's recommendation and testimony, reminding Rice that the Project was and is opposed to the reclassification of ECT devices to either Class II or Class I. Rosenberg then further explains how they came to their conculsion. He informs Rice that they provided the panel at the testimony with the legally sound, nonrhetorical analysis. At the end of the day, the Project was informally advised that the panel would recommend to the FDA their exact proposal, which was reclassification contingent upon the development of performance standards.
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