Judy K Burton - Comment
The is a Comment on the Food and Drug Administration (FDA) Notice: Medical Device User Fee Act Public Meeting
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It would be easier to understand FDA requiring more funding if I had experienced working with FDA personnel who were better trained and worked harder at their jobs. As it stands, I have had a reviewer tell me to "ignore the ball game in the background" when on a conference call to answer questions for a 510(k) submission.
Additionally, personnel who have "been at the same desk for 13 years" are incapable of answering such simple questions as which division to consult about a device which has an established product code and regulation number.
I acknowledge that delays occur due to poorly prepared submissions. However, adding more layers and more charges will not solve the problems that result from inadequate training, high staff turnover and apathy (because government employees can't be fired).
This is corporationism at best. Small medical device companies will be forced out of business, thus eliminating competition for big industry. FDA is currenlty repeating the same process the EU drug regulations underwent in the 1980's. The end result was that private industry ended up forming organizations that were responsible for setting the standards instead of the government.
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Comment Period Closed
Apr 16 2012, at 11:59 PM ET
Tracking Number: 80ff1f61
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Date Posted: Apr 17, 2012
Country: United States
State or Province: TX
Category: Device Industry - C0012