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Contacting the FDA

Posted by BrianG on 4/11/01 at 10:19 (044250)

Recently Dr. Z suggested we all contact the FDA to let them know how we feel about the ESWT trials that have been going on. I did just that. I urged them to hurry the process to get more machines approved, so that the insurance companies would be forced to start covering the procedure.

To call the FDA, the tel number is 1-888-INFO-FDA or 888-463-6332. I did it over the net, at http://www.fda.gov/
Scroll down to the bottom of the home page to the area that says 'Let us hear from you' Click on 'Contact FDA'. This is a good page for contact information. Also, at the bottom of the page you can also click on 'Search' I typed in 'Ossatron' and found out 'MUCH' information. You can read all about the trials that the HealthTronics people had to go through to get their machine (Ossatron) approved. I was very interested in the side effects during the trials. No one in the trials had severe, or worse, pain after their treatments. A couple people had mild pain, which resolved itself, spontaniously, soon after the treatments.

This might be some good reading for folks considering ESWT, as there seems to be a lot of pain being reported on the message board lately. An informed consumer will end up making the best choices. This is a very good place to start.

Regards
BCG

Re: Contacting the FDA

Dr. Zuckerman on 4/14/01 at 10:07 (044562)

Hi,

This is a very interesting lack of reponse to this very important action.

It is one of the most important ways to reduce the fees associated with ESWT treatments and to make the market open up. Now I tend to be impatient and want to see the market open up quicker. Maybe the status quoto is find and then maybe it isn't . If you feel that it isn't this would be one of the way to help reduce the time . There is no question in my mind that the PMA process will be changed someday the question is just how long it will take.

We have the experience and history for ESWT lithotripsy, Just don't understand why the FDA can't use this information and experience for orthopedic ESWT. I like to call it podiatric ESWT since I have been told that there are now more podiatrists using ESWT for pf not then orthopedics

Re: Contacting the FDA

BrianG on 4/14/01 at 17:27 (044622)

I was wondering the same thing myself. This post sat there all alone, for days. Didn't anyone feel the need to let the FDA know how we feel, or least use the search feature? Is it apathy, or something else?

BCG

Re: Contacting the FDA

Pauline on 4/14/01 at 21:13 (044632)

Hi Brian,
If you read my latest postings you know I've done as you suggested. I also wrote a letter to the Advisory Board when the Ossatron was up for approval. I received notification that my letter was read at the meeting. I tried to encourage others to write as well and I believe there were 3 of us that did. You never know where you make a difference so I like you believe that personal letters count a great deal.

Re: Contacting the FDA

Nancy N on 4/15/01 at 08:08 (044654)

Brian--

Please bear in mind two things:

1. It's entirely possible that people took up your suggestion and simply didn't post a reply saying so on the board.

2. This past week was a busy holiday week for a lot of people, so they may not have had the time to do anything or to post as such on the board.

Re: Contacting the FDA

BrianG on 4/15/01 at 11:55 (044666)

Thanks, your both right. I just haven't had the time to read every post, but I see what your talking about Pauline. I thank god I found this message board, there is so much to learn.

BCG

Re: Nancy's right...

Valerie S on 4/17/01 at hrmin (044799)

Hi.
I contacted the FDA, just like you told me to. I went through the links you gave and sent an email, and received a generic reply, so just hope the right people read it...
Thanks for the information.
Val.

Re: Contacting the FDA

Dr. Zuckerman on 4/14/01 at 10:07 (044562)

Hi,

This is a very interesting lack of reponse to this very important action.

It is one of the most important ways to reduce the fees associated with ESWT treatments and to make the market open up. Now I tend to be impatient and want to see the market open up quicker. Maybe the status quoto is find and then maybe it isn't . If you feel that it isn't this would be one of the way to help reduce the time . There is no question in my mind that the PMA process will be changed someday the question is just how long it will take.

We have the experience and history for ESWT lithotripsy, Just don't understand why the FDA can't use this information and experience for orthopedic ESWT. I like to call it podiatric ESWT since I have been told that there are now more podiatrists using ESWT for pf not then orthopedics

Re: Contacting the FDA

BrianG on 4/14/01 at 17:27 (044622)

I was wondering the same thing myself. This post sat there all alone, for days. Didn't anyone feel the need to let the FDA know how we feel, or least use the search feature? Is it apathy, or something else?

BCG

Re: Contacting the FDA

Pauline on 4/14/01 at 21:13 (044632)

Hi Brian,
If you read my latest postings you know I've done as you suggested. I also wrote a letter to the Advisory Board when the Ossatron was up for approval. I received notification that my letter was read at the meeting. I tried to encourage others to write as well and I believe there were 3 of us that did. You never know where you make a difference so I like you believe that personal letters count a great deal.

Re: Contacting the FDA

Nancy N on 4/15/01 at 08:08 (044654)

Brian--

Please bear in mind two things:

1. It's entirely possible that people took up your suggestion and simply didn't post a reply saying so on the board.

2. This past week was a busy holiday week for a lot of people, so they may not have had the time to do anything or to post as such on the board.

Re: Contacting the FDA

BrianG on 4/15/01 at 11:55 (044666)

Thanks, your both right. I just haven't had the time to read every post, but I see what your talking about Pauline. I thank god I found this message board, there is so much to learn.

BCG

Re: Nancy's right...

Valerie S on 4/17/01 at hrmin (044799)

Hi.
I contacted the FDA, just like you told me to. I went through the links you gave and sent an email, and received a generic reply, so just hope the right people read it...
Thanks for the information.
Val.