Wednesday, August 28, 2013

FDA Notice of Action for Detention of Imported Food Products and Electronic Submission of Private Lab Reports to FDA via ITACS

When imported cargo is detained by the U.S. Food and Drug Adminsitration (FDA), speed in responding to FDA's requests is crucial. The attorneys of GrayRobinson's Customs and International Trade Law Group understand the importance of responsiveness with FDA Notices of Action. Our goal is to have our clients' shipments released quickly.

Import Trade Auxiliary Communication Systems (ITACS) assists importers in responding to an FDA Notice of Action quickly, getting the FDA the lab testing they need to authroize release of the detained shipment.

It is the preference of the FDA for private laboratory analytical reports to be submitted in an electronic format for greater ease and speed of processing by FDA. The FDA’s ITACS “External Lab Analytical Package” document type provides users an additional means of submitting private laboratory analytical reports in an electronic format.

FDA has an automated process for the routing and review of private laboratory analytical reports which allows FDA to process private laboratory analytical reports submitted via electronic means more quickly than private laboratory analytical reports submitted in hard copy forms. In order to avoid potential delays, private laboratory analytical reports should be submitted electronically via ITACS.

All analyses conducted by private laboratories and the reports submitted for those analyses are expected to conform to the guidance found in FDA’s ORA Laboratory Manual, Volume III, Section 7, Private Laboratory Guidance. General instructions on how to use ITACS to submit documentation and information to the FDA is available online here.
For more information on how to effectively respond to an FDA Notice of Action to get your detained shipments released quickly, please contact:


Peter Quinter, Esq.
Chair, Customs and International Trade Law Group
Shareholder, GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131

Direct: 305-416-6960




Monday, August 12, 2013

FDA PUBLISHES 2014 MEDICAL DEVICE FEES FOR SMALL BUSINESSES

On August 2, 2013, U.S. Food and Drug Administration (FDA) published Guidance for Industry and Food and Drug Administration Staff and Foreign Governments: FY 2014 Medical Device User Fee Small Business Qualification and Certification.
The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of these user fees. This guidance describes the process for how a business may request qualification and certification as a small business. A business that qualifies as a “small business” is eligible for a significant reduction in the fees.
The full PDF version of this FDA guidance is available here.
FDA's medical device fees increase to $3,313 at the start of the FDA's 2014 fiscal year. No small business reductions are available for this particular fee.
For more information on FDA's establishment registration requirements for medical device companies and how to qualify for reduced FDA fees in 2014, please contact:

Peter Quinter, Esq.
Chair, Customs and International Trade Law Group
Shareholder, GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131
Direct:  305-416-6960