Maine Molecular Quality Controls, Inc. - Comment

The is a Comment on the Food and Drug Administration (FDA) Notice: Medical Device User Fee Act Public Meeting

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Comment

Dear FDA,

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.

Sincerely,
Joan Gordon, MT (ASCP)
____________________
Joan Gordon, President
Maine Molecular Quality Controls, Inc.
10 Southgate Road, Suite 170
Scarborough, Maine 04074
Ph: 207-885-1072
Fax: 207-885-1079
 
 
Comment Period Closed
Apr 16 2012, at 11:59 PM ET
ID: FDA-2010-N-0389-0019
Tracking Number: 80fdc9d3

Document Information

Date Posted: Mar 27, 2012
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Submitter Information

Country: United States
State or Province: ME
Category: Device Industry - C0012