Guest guest Posted May 26, 2011 Report Share Posted May 26, 2011 unless, of course, the pharm company has the lobbyists to push the med or program into the fast track. Like they did with Vioxx. And then what happened? Rolls eyes. Wondering why they just don't recreate the FDA from scratch. Printing a log from the Prodigy Voice Advanced Diabetic Supplies is requesting a log for their records since my daily strip need is above the guidelines for insulin dependent diabetics (3 per day!). So, how can I do this, assuming I can, with my sighted wife's assistance of course? Thanks. Dave -- Weather conditions on 3/22/2011 5:04:25 PM in Lancaster, Pennsylvania Mostly Clear, 52.0°F Wind:NW-320° at 8mph gusting to 16mph Join the BARD Talk list: bardtalk-subscribe <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> Visit the BARD Talk web site: http://www.bardtalk.com Created by Weather Signature v1.32 . http://www.weathersig.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2011 Report Share Posted May 26, 2011 unless, of course, the pharm company has the lobbyists to push the med or program into the fast track. Like they did with Vioxx. And then what happened? Rolls eyes. Wondering why they just don't recreate the FDA from scratch. Printing a log from the Prodigy Voice Advanced Diabetic Supplies is requesting a log for their records since my daily strip need is above the guidelines for insulin dependent diabetics (3 per day!). So, how can I do this, assuming I can, with my sighted wife's assistance of course? Thanks. Dave -- Weather conditions on 3/22/2011 5:04:25 PM in Lancaster, Pennsylvania Mostly Clear, 52.0°F Wind:NW-320° at 8mph gusting to 16mph Join the BARD Talk list: bardtalk-subscribe <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> Visit the BARD Talk web site: http://www.bardtalk.com Created by Weather Signature v1.32 . http://www.weathersig.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 27, 2011 Report Share Posted May 27, 2011 Thanks for the info Ruth, I will hang in there with my Prodigy as it is and hope for early confirmation! Did Canada every get the Prodigy approved? _____ From: blind-diabetics [mailto:blind-diabetics ] On Behalf Of ruth hogue Sent: Thursday, May 26, 2011 1:57 PM To: blind-diabetics Subject: RE: Printing a log from the Prodigy Voice Hi Allan, All I know is what I was told which is that the FDA requires the software needs to be approved by the FDA. My guess is that FDA rules have changed and it is now required for software. Remember, the software was changed for the Voice since it was first developed because it was not working well. In the meantime, rules may have changed so D.D.I. must conform to rules. I am from Canada and I know that Canada Health changes rules from time to time and you can get caught in the middle of these changes and then have to conform. That’s all that I can figureout has happened. Ruth From: blind-diabetics <mailto:blind-diabetics%40yahoogroups.com> [mailto:blind-diabetics <mailto:blind-diabetics%40yahoogroups.com> ] On Behalf Of Alan Lemly Sent: Thursday, May 26, 2011 3:15 PM To: blind-diabetics <mailto:blind-diabetics%40yahoogroups.com> Subject: RE: Printing a log from the Prodigy Voice Ruth, perhaps you can explain this FDA approval issue further since I thought that sounded like a lame excuse when the Prodigy representative told it to me. I would have thought getting FDA approval for the device itself would have been the difficult issue and that the FDA wouldn't care much about software that worked with an approved device. Didn't the device have to be originally designed so that it would work with a computer? I would have thought that any software to transfer its logs to a computer would have been in the original design and already covered by FDA approval. This just sounds like someone's making an excuse to hide a serious shortcoming. Alan Lemly Re: Printing a log from the Prodigy Voice Yeah, well, I keep thinking we'll hear from Ruth or someone who has some new information about this. The silence is deafening. Dave " ...In this world you will have trouble. But take heart! I have overcome the world. " [ 16:33] Printing a log from the Prodigy Voice Advanced Diabetic Supplies is requesting a log for their records since my daily strip need is above the guidelines for insulin dependent diabetics (3 per day!). So, how can I do this, assuming I can, with my sighted wife's assistance of course? Thanks. Dave -- Weather conditions on 3/22/2011 5:04:25 PM in Lancaster, Pennsylvania Mostly Clear, 52.0°F Wind:NW-320° at 8mph gusting to 16mph Join the BARD Talk list: bardtalk-subscribe <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> <mailto:bardtalk-subscribe%40yahoogroups.com> Visit the BARD Talk web site: http://www.bardtalk.com Created by Weather Signature v1.32 . http://www.weathersig.com Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.