2017 - Page 8 of 9 - Customs & International Trade Law Firm

Keep Your Eyes Peeled For the Single Export Licensing System!

Currently the U.S. government has three different agencies that have been given the authority to issue export licenses. Those three agencies are: the Departments of Commerce, State, and the Treasury. In 2009, President Obama ordered an interagency review of the current export control system. The review found that the current system was “overly complicated, contained too many redundancies, and, in trying to protect too much, diminished the ability to focus their efforts on the most critical national security priorities”. The review also found that many companies had to apply for multiple export licenses with each of the departments. Due to the findings of the review, the Administration created the Export Control Reform initiative to help establish a single export licensing system.

“The goal of the (ECR) initiative is to create a Single Licensing Agency (SLA), which would act as a ‘one stop shop’ for businesses seeking export license and for the US government to coordinate review of license applications.” The ultimate goal of this new licensing process would be to make the process predictable, timely, and transparent.

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By Jennifer Diaz|2022-07-07T12:02:32-04:00February 6, 2017|Export|0 Comments

Medical Device Registration Made Easy!

This article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.

FDA’s classes of medical devices:

“The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.”

The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.

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By Jennifer Diaz|2022-07-07T12:01:38-04:00January 27, 2017|Export, FDA Issues, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|4 Comments

Top Successes of Diaz Trade Law (DTL) & Diaz Trade Consulting (DTC) in 2016!

DTL saved clients MILLIONS of dollars in 2016, below we list a summary of some of our compliance successes!

U.S. Customs & Border Protection (CBP)

Assisted an importer in having $434,486.00 worth of goods seized returned to it in a RECORD 24 working days, with a signed settlement agreement with CBP in a record 17 working days!
Assisted an importer in having $324,466.00 worth of goods seized for an underlying AES violation returned.
Assisted importers in filing prior disclosures that were accepted by CBP, advising of errors found, and avoiding substantial penalties.
Assisted importers in successfully responding to CBP 28’s and 29’s resulting in close outs, and no further enforcement action by CBP!
Assisted importers in creating and maintaining pre-compliance programs to evaluate intellectual property rights and pre-report merchandise to CBP resulting in expedited entry into the U.S. with no delays or examinations by CBP.

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By Jennifer Diaz|2022-07-07T12:00:14-04:00January 26, 2017|Best Practices, CBP 28, CBP 29, Cuba, Expert, FDA Issues, Pre-compliance, TSA, U.S. Customs and Border Protection (CBP), U.S. Federal Maritime Commission (FMC), U.S. Food and Drug Administration (FDA)|0 Comments

Catch up on DTL’s TOP Blogs from 2016!

We want to make sure you stay up to date with the hottest trade topics from 2016. Below is a summary of what you missed by category. Enjoy!

CBP

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By Jennifer Diaz|2022-07-07T11:58:48-04:00January 26, 2017|AD/CVD, Best Practices, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments

VW to pay HIGHEST CBP PENALTY EVER, $1.45 Billion!

On January 11, 2017, the U.S. Customs and Border Protection (CBP) and the Attorney General announced the largest criminal and civil settlement ever against Volkswagen (VW) that totaled $4.3 billion. The breakdown of the settlement was $2.8 billion for the criminal penalty and $1.45 billion for a combined civil penalty for both the CBP and the Environmental Protection Agency (EPA). Volkswagen agreed to plead guilty to three felony criminal counts and pay the $2.8 billion dollar penalty. The $1.45 billion combined settlement was for EPA’s “claim for civil penalties against VW in connection with VW’s importation and sale of these cars” as well as CBP’s claim for customs fraud.

CBP’s part of the $1.45 billion settlement dealt with a violation of 19 U.S.C. §1952, which “prohibits persons, by fraud, gross negligence or negligence, from entering or introducing, attempting to introduce, or aiding and abetting the entry or introduction of merchandise into the commerce of the United States, by means of statements or acts that are material and false, or by means of omissions which are material”.

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By Jennifer Diaz|2022-07-07T11:57:49-04:00January 19, 2017|Import, Investigation, U.S. Customs and Border Protection (CBP), U.S. Environmental Protection Agency (EPA), Vehicles|0 Comments

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