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Thursday, January 31, 2013

FDA Now Double-Dipping with Facility Registration Fees

FI Sales does not manufacture or import any medical devices that require FI Sales to list them with the FDA.  The FDA does not monitor our facility or our products.  We never see an FDA inspector.  We have nothing to inspect.  The FDA has to expend zero time and effort regarding FI Sales.  Up until 2013, FI Sales dutifully registered with the FDA as a reseller and importer of FDA-approved devices from manufacturers with FDA-approved facilities.  The suppliers to FI Sales list their medical devices with the FDA and pay the required fees for the FDA to monitor their compliance.  So there should be no way the FDA would require FI Sales to pay as much as one penny to sell medical products, right? 

That was correct up until 2013.  With bipartisan support from our legislators, a new law now allows the FDA to charge multiple companies for the right to sell the same product in the USA.  Here’s an example:
·         Protec Medical in Germany pays an annual fee for the FDA to monitor compliance with FDA practices in the manufacture of x-ray film processors.  That should be the one and only fee.

·         FI Sales in the USA now pays an annual fee to be listed as the initial importer of Protec x-ray film processors.  That’s a second fee for the same product, and the FDA has no interaction with FI Sales other than collecting the fee.

As for our legislator’s rhetoric about helping small business, rhetoric  is all it is.  Their actions and votes allow more fees (taxes) to be imposed upon small businesses like FI Sales.  This legislation now allows the FDA to charge multiple companies for the right to sell the same product.  Double-dips are good for ice cream cones, but in this case just equate to another regressive tax that our government has imposed upon us.