Medical Devices Advisory Committee




НазваниеMedical Devices Advisory Committee
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Thank you very much. I would also like to take this time to formally turn the panel executive secretary over to Veronica Calvin, who will be taking over the duties. And thank you again. This concludes the meeting.

DR. NIPPER: Hang on one more minute.

We have one more job to do and it is a very brief one.

MS. LAPPALAINEN: This is regards to the vote and the conditions that were imposed. I would like to go around the table one more time and express why certain conditions were imposed; for example, why -- what are the reasons behind imposing a premarket versus, say, a postmarket. The reason why you voted approvable --

DR. NIPPER: Eventually we will get it right.

Dr. Rej, would you please tell us why you voted the way you did?

DR. REJ: Certainly for the labeling, I think that the labeling is a relatively minor --

DR. NIPPER: Why did you vote for approval as opposed to disapproval or --

DR. REJ: I voted for approval because I believe that the deficiencies in the submission are relatively minor and can be corrected, a few in a premarket manner and the others in a postmarket manner. Is that sufficient?

DR. NIPPER: Dr. Woody Lewis, tell us why you voted the way you did, please?

DR. LEWIS: Yes. Sherwood Lewis.

For the very same reasons as Dr. Rej expressed and in order to keep it simple rather than just reiterate, I voted approvable and I feel that those things which should be done premarket are important and yet will not impede the progress forward for this very important device.

As to the labeling, I think that has been well spoken to and I only think that it is important that the labeling be such that the user himself or herself and the clinician taking advantage of this information has it presented in the simplest and most easily understandable fashion.

I think those are the only two points that I would address here.

DR. NIPPER: Thank you.

Dr. Cooper.

DR. COOPER: I voted approvable because the deficiencies are minor and I suggested that they be postmarket because the sponsor has shown great cooperation with the FDA and the FDA has validated that cooperation and I believe that together they can work out the differences.

DR. NIPPER: Thank you.

Dr. Kroll.

DR. KROLL: Again, I voted approval because I thought the deficiencies were minor. I thought some of the conditions needed to be premarket because they are special patient populations either by ethnic group or by certain conditions, which may actually potentially demonstrate their problems with interpreting the results and that should be known about beforehand, but I think it is not that difficult to obtain that information.

For the bilirubin, again, that is one that is commonly known as a major interferer and, again, that could be obtained beforehand because it is not that difficult and also can be useful to demonstrate.

DR. NIPPER: Thank you.

Dr. Falls, explain briefly why you voted the way you did.

DR. HARRINGTON FALLS: I voted approvable with conditions. I believe it will be an important tool to identify, motivate, provide feedback and improve compliance in patient health care.

DR. NIPPER: Thank you.

Dr. Rosenbloom.

DR. ROSENBLOOM: I voted approval with post -- with the conditions being postmarket because I felt that sufficient data was available to do that and that the sponsor has every reason to pursue the postmarket suggestions that were made because they make enormous marketing sense.

DR. NIPPER: Thank you.

Dr. Clement.

DR. CLEMENT: I voted for approval with postmarketing mainly because I am swayed by my chemical and diabetes educator colleagues on the other side and also because of the track record of the company on cooperation, I think this can be done postmarketing.

DR. NIPPER: Dr. Everett.

DR. EVERETT: I voted approvals with premarket conditions and, again, I am probably -- as I have already stated and that is that if you going to use something in a group of people, you should at least try it in that group of people. It is in my mind a disservice to try it in people who you have never used them before, even though the risk is small. So, I decided that it should be approved.

DR. NIPPER: Thank you.

Dr. Janosky.

DR. JANOSKY: I voted approvable with conditions. There were some deficiencies and I think those deficiencies are minor, but just for clarification, premarket and --

DR. NIPPER: Thank you very much.

I hope we have met the letter and the spirit of the rules in doing our jobs today. I would like to thank everybody on the FDA side, on the sponsor's side for doing their jobs very well, in particular the evaluation team, whose names Dr. Gutman put up earlier and whose names I have folded into my folder and can't read. But I do thank all of the FDA staff, who has done such an excellent job here today and I thank all the public commenters, who have gone and haven't stayed around for the last gasp. We appreciate everything you have done to bring this important product further down the road toward marketing.

The meeting is adjourned.

[Whereupon, at 5:17 p.m., the meeting was concluded.]
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