FDA's New eCopy Submission Requirement for 510(k) Medical Device Approvals

Effective January 1, 2013, the U.S. Food and Drug Administration (FDA) will only review a premarket submission if it has an electronic copy (eCopy) that has been validated by FDA's eCopy loading system. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive.

This means that 510(k)'s and applications for Premarket Approval (PMA's) which are not submitted to FDA in both hard copy and eCopy format will be rejected. An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission. The signed eCopy statement must say: THIS ECOPY IS AN EXACT DUPLICATE OF THE PAPER COPY.

Failure to submit these two additional items will delay the review, and, therefore, required approval, of your medical device with FDA. For detailed information on FDA's new eCopy program, read FDA's final guidance: eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff. 

For more information on medical device compliance with the FDA, 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

peter.quinter@gray-robinson.com

Rebecca Rodriguez

Customs and International Trade Law Group

Law Clerk*, GrayRobinson, P.A.

1221 Brickell Avenue, Suite 1600

Miami, Florida 33131

Direct: 305-913-0536

rebecca.rodriguez@gray-robinson.com



*Not licensed to practice law in Florida.

IS YOUR CONDOM COMPLIANCE SAFE?

Many of you may think of a condom as a way to avoid pregnancy, but to a customs and international trade attorney, men’s latex condoms are Class II “medical devices” regulated by the  U.S. Food and Drug Administration (FDA). There are several compliance issues that arise when attempting to import condoms into the United States.

Attempting to import any medical device into the United States can be a complicated endeavor. Failure to handle these compliance matters ahead of time can lead to an FDA detention and potential FDA refusal of the shipment. U.S. Customs and Border Protection (CBP) and FDA will  investigate several of these compliance requirements when your shipment arrives into the U.S., including:

• Whether a 510(k) Premarket Notification was approved by FDA for the device;
• Whether the importer of record filed Device Initial Importer Registration with FDA; and
• Whether the foreign manufacturer filed the Device Facility Establishment Registration with FDA.

With these compliance matters, cheap becomes expensive very quickly. Regulatory compliance matters are better handled before any shipments are sent. For some information on the requirements for filing a 510(k) premarket notification with FDA for latex condoms, visit FDA's website, click here. For some information on the labeling requirements for men's latex condoms visit FDA's website, click here. For everything else you want to know about condoms, please contact one of the Customs and International Trade Law Group members at GrayRobinson.

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

peter.quinter@gray-robinson.com

Rebecca Rodriguez

Customs and International Trade Law Group

Law Clerk*, GrayRobinson, P.A.

1221 Brickell Avenue, Suite 1600

Miami, Florida 33131

Direct: 305-913-0536

rebecca.rodriguez@gray-robinson.com

Photo credit: Writing on the Wall

*not licensed to practice law in Florida

10 MOST COMMON MISCONCEPTIONS IN INTERNATIONAL TRADE

I have been an international trade attorney for over twenty years.  In that time, I have represented a few thousand companies involved in the importation, exportation, and international transportation of merchandise.  I have seen respectful, efficient U.S. Government employees and the most uncaring bureaucrats, importers who care about the law and others who only care how to get around it, and customs brokers who always try to do the right thing and others who you wonder how they ever passed the broker exam and the background check. I have listed the 10 Most Common Misconceptions in International Trade.

I have actually heard intelligent people who are CEOs or General Counsels of their companies say the most surprising things to me over the years.

1.  It is ok to bring in up to $100 worth of Cuban cigars into the United States.

2.  Dietary supplements that are "all natural" are not regulated by the U.S. Food and Drug Administration (FDA), and, therefore, can make all kinds of medical claims.

3.  The U.S. Government does not care about the value of cargo being exported from the United States because there are no duties, taxes or fees paid to the U.S. Government on exports.

4.  If an airlines passenger brings into the United States over $10,000 in cash, the passenger must pay a tax to U.S. Customs or the IRS.

5.  If an importer uses a customs broker to file an entry with U.S. Customs and Border Protection, and some false information is provided to U.S. Customs, only the customs broker is liable to U.S. Customs, not the importer.

6.  No one gets hurt by importing, buying and selling counterfeit merchandise.

7.  If some food product is marked with "Made in America" it must be good, but if it is marked "Made in China" then it must be bad.

8.  If an imported item is marked "Made in Vietnam" or "Made in Malaysia" or "Made in America" then if really must have been manufactured or produced in the identified country, and no other.

9. Since it is illegal to sell military items to places such as North Korea and Iran, if a U.S. company ships those items to a friendly country such as Australia or England, and the buyer in those countries then re-export them to North Korea or Iran, the U.S. company has done nothing wrong.

10.  A product manufactured in India, transported to Mexico, and then imported into the United States from Mexico should enter duty free under NAFTA because Mexico and the United States are members of the North American Free Trade Agreement (NAFTA).

Peter Quinter, Chair
Customs and International Trade Law Group
GrayRobinson, P.A.
peter.quinter@gray-robinson.com
Direct: (305) 416-6960
Miami, Florida

TTB 2012 Annual Report Released

On March 22, 2013, the Alcohol Tobacco Tax and Trade Bureau ("TTB") announced the release of the TTB 2012 Annual Report. TTB is the third largest tax collection agency in the U.S.Government, behind the Internal Revenue Service (IRS) and U.S. Customs and Border Protection (CBP). In 2012, TTB collected $23.4 billion in alcohol, tobacco, firearms and ammunition excise taxes—a decrease of less than a half of 1 percent compared to 2011. Prior to 2008, TTB and its predecessor—the Bureau of Alcohol, Tobacco and Firearms (ATF)—collected between $14 - $15 billion in excise taxes annually. Now, for the fourth consecutive year, TTB tax collections have exceeded $23 billion.

Collection of Excise Taxes

As an agent of the Federal Government and as authorized by 26 U.S.C., TTB collects excise taxes from alcohol, tobacco, firearms, and ammunition industries. TTB collected approximately $78 million less in excise taxes compared to the previous fiscal year. In 2011, TTB collected $23,457,049,000 in excise taxes. In 2012 a decrease to $23,378,944,000.

Fines, Penalties and Interest

TTB collected approximately $3.4 million less in fines, penalties and interest in 2012. In 2012, TTB collected $937,000 in fines, penalties and interest. However, in 2011, TTB collected an astounding $4,361,000 in fines, penalties and interest.

Prospectus for TTB

In forecasting tobacco revenues, Federal collections are expected to decline after peaking at $15.9 billion in 2010. Higher prices on tobacco products have historically resulted in decreased consumption and increased illicit trade, which combined would indicate declining tax revenues in the out years.

TTB efforts in enforcing both its civil and criminal tax jurisdiction support voluntary tax compliance and act to deter illicit trade, and TTB will continue to act to address the revenue threat posed by the diversion of alcohol and tobacco products to ensure the collection of the taxes due.

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

peter.quinter@gray-robinson.com

Rebecca Rodriguez
Law Clerk
Customs and International Trade Law Group
GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131
Direct: 305-913-0536
rebecca.rodriguez@gray-robinson.com

TSA Compliance for Indirect Air Carriers

The Transportation Security Administration (TSA) cargo security requirements for indirect air carriers (IACs) are again undergoing a dramatic change.  As international freight forwarders a/k/a indirect air carriers have noticed, there are increased visits by TSA personnel to warehouse facilities resulting in an increased number of violations and penalties against IACs.

The National Educational Institute (NEI) of the National Customs Brokers and Forwarders Association of America (NCBFAA) is hosting a webinar entitled "TSA Compliance for IACs" on Thursday, February 28, 2013, from 1:00 to 2:00 p.m. EST. to discuss:

1. How To Mitigate Penalties Assessed by TSA
2. Transporation Security Regulations in 49 CFR   
3. Certified Cargo Screening Program (CCSP)
4. National Country Security Program (NSCP)
5. Air Cargo Advanced Screening Program (ACAS)

 The Presenters will be Brandon Fried, Executive Director, AirForwarders Association, a Washington, D.C. based organization representing the air freight forwarding industry, and Peter Quinter, Shareholder and Chair of the Customs and International Trade Law Group at the law firm of GrayRobinson.  Mr. Quinter represents air carriers and IACs regarding TSA compliance and penalty matters.

Registration for the webinar is through the NEI by email at NEI@NCBFAA.org or (202) 466-0222. For more information about the webinar, click here.

For questions about TSA matters generally, please comment below or contact directly:

Peter Quinter, Chair
Customs and International Trade Law Group
GrayRobinson, P.A.
email: peter.quinter@gray-robinson.com
Phone (954) 270-1864
Miami, Florida

Seafood and FDA and CBP Requirements at International Boston Seafood Show

  Please join me at the International Boston Seafood Show (IBSS), on March 11, 2013, from 3:30 to 5:00 p.m, a panel of legal experts and managers from the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) will discuss what seafood importers need to know to comply with Government requirements and avoid delays, seizures, and penalties.  The Federal Food Safety and Modernization Act (FSMA) and its many implementing regulations by the FDA for prior notice by importers and registration of food facilities will be explained.  Buyers, sellers, air and ocean carriers, trucking companies, distributors, importers, and anyone who handles seafood should be well aware of the new legal requirements.

Learn what the Government is doing to be sure that the seafood imported into the United States is safe to eat, from a reliable source, and properly described and labeled. That and much more will all be addressed in this panel discussion followed by a question and answer session.  As in the past two years, this regulatory panel has been praised by attendees and been the highest rated panel presentation at the IBSS.

Peter Quinter will moderate the panel as well as introduce the policies and procedures of both the FDA and CBP in selecting, holding, sampling, testing, and either releasing or refusing imported seafood.  There will be an extensive discussion of Import Alerts and Detention Without Physical Examination (DWPE) particular to seafood.

Peter Quinter, Chair
Customs and International Trade Law Group
GrayRobinson, P.A.
peter.quinter@gray-robinson.com
Direct: (305) 416-6960

Customs Seizes NFL Counterfeit Merchandise

U.S. Customs and Border Protection (CBP) officers in cooperation with Special Agents from Homeland Security Investigations (HSI) of the U.S. Department of Homeland Security made a spectacular bust of a ring of counterfeiters in New Orleans prior to the Superbowl.  Arrests were made and millions of dollars of allegedly counterfeit merchandise were seized.  This is just the latest incident in the daily activities of both CBP and HSI officers to attempt to stop the importation, distribution, and sale of counterfeit merchandise.  Statistically, 2012 was a record year for CBP with $1.26 billion in counterfeit merchandise seized and 691 arrests, according to CBP Assistant Commissioner Al Gina.  

Every year, CBP reports its statistics of seizures of counterfeit merchandise. The trend is clear; it is up because there is simply more counterfeit merchandise entering the United States each year from countries such as China, Mexico, and Vietnam.  One day it may be counterfeit NFL team jerseys, the next day it will be counterfeit birth control pills, or counterfeit auto parts.  Counterfeiting is a multi-billiion dollar business.  

Americans apparently support it because we are huge consumers of counterfeit merchandise.  Most consumers of counterfeit merchandise know they are buying a knock-off because instead of paying $5,000 for a genuine Rolex watch, the $50 counterfeit look alike seems like a good deal.  That occurs whether the illegal purchase and sale is at a flea market or on the Internet.

CBP is, however, often simply wrong when it detains, and then seizes, merchandise it suspects is counterfeit.  In those situations, an attorney very familiar and experienced in challenging such detentions or seizures becomes critical to obtain the release before the value is significantly decreased and delivery can still be made to the customer.  Plus, a huge fine can be issued by CBP to any importer for a violation of 19 USC 1526(f) when the importer attempts to import counterfeit merchandise, so avoiding or mitigating that fine through the CBP administrative petition process becomes paramount.

Peter Quinter, Chair

Customs and International Trade Law Group

GrayRobinson law firm

peter.quinter@gray-robinson.com

Direct Phone (305) 416-6960