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HI JERRY, jhstarr wrote: > > DEAR CHARLIE: THANKS FOR THE INFO ON THE RELEASE OF PENCIL. I have > several questions that your FDA source could possibly answer. > 1.Have there been any studies to assess the safety in the geriatric > population? That is an interesting question. The geriatric population actually tolerates the switch to PENCIL better than younger patients. It is almost as though they are not naive subjects and have a lot of comfort with the device. Younger patients tend to go through a longer period of adjustment. It probably has something to do with the sudden withdrawal of KEYBOARD or JOYSTICK but why the difference between the age groups is unknown. > 2.Has any consideration been given to issuing a warning of use by > persons with severe dyskinesia. The possibility of launching the > device across the room and injuring any exposed surface exsists. As you are aware there is no specific requirement regarding risk to property or bystanders to be reported to the FDA. I suspect that the manufacturer is using this technicality to avoid putting the info in the Package insert although the the pre-marketing experience does suggest that it happens with a fair amount of frequency. 3. Has eraser been approved yet? Toxicology studies are incomplete at this point especially in the fixed Combination Pencil with Eraser. The device is reported to be abused by patients chewing on the end so complete tox evaluation must be done prior to any release. > 4.Has the protocol for post marketing survalance been > established. > Jerry Starr, RPh With the recent release of PAPER and the imminent release of ENVELOPE and STAMP it is suggested at this point that Escargot-mail be utilized. Hope this answers your questions- Charlie -- ********************************************************** CHARLES T. MEYER, M.D. MADISON, WISCONSIN **********************************************************