Home » FDA Calls Study Criticizing HDE Biased, Riddled With Omissions
FDA Calls Study Criticizing HDE Biased, Riddled With Omissions
The FDA has found several flaws in a study that claims its humanitarian device exemption (HDE) program is being improperly used to allow deep brain stimulation (DBS) to treat resistant obsessive-compulsive disorder (OCD). An HDE is reserved for conditions that afflict fewer than 4,000 patients, a standard the study’s lead author, Weill Cornell Medical College ethicist Joseph Fins, does not believe has been met in this instance. Fins and the study’s co-authors voice concern that HDE allows manufacturers to seek a “simpler, cheaper and faster approval process” while depriving patients of “the rigorous trial that … their condition warrants, as well as hampering scientific discovery.”
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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