Maine Molecular Quality Controls, Inc. - Comment
This is a Comment on the Food and Drug Administration (FDA) Notice: Medical Device User Fee Act Public Meeting
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I would like to point out that not all ‘small businesses’ are the same size. We are a 7-person company that manufactures quality controls for molecular diagnostic tests. Obviously our resources are significantly less than a 499-person company, or larger as now allowed under the expanded definition of ‘small business’. In accordance with our quality goals as a company and the guidance “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” issued on June 1, 2011, we intend to bring all our current products and our future products to FDA for review. However, the current fee structure is a factor in delaying FDA submission for this 7-person company. The proposed increase in FDA fees will be overly burdensome.
Please consider creating a category for ‘micro-businesses’ when revising your fee structure and do not increase the fees for those companies.
Joan Gordon, MT (ASCP)
Joan Gordon, President
Maine Molecular Quality Controls, Inc.
10 Southgate Road, Suite 170
Scarborough, Maine 04074
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Comment Period Closed
Apr 16 2012, at 11:59 PM ET
Tracking Number: 80fdc9d3
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Date Posted: Mar 27, 2012
Country: United States
State or Province: ME
Category: Device Industry - C0012