Monthly Archives

January 2017

ExportFDA IssuesImportMedical Devices

Medical Device Registration Made Easy!

posted by Jennifer Diaz January 27, 2017 1 Comment

Screen Shot 2017-01-26 at 1.40.53 PMThis 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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Best PracticesBISCBPCosmeticsCubaEventsExportFDA IssuesImportIPR, Trademarks and LogosSeizuresSpeakingU.S.Customs

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

posted by Jennifer Diaz January 26, 2017 0 comments

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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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CBPEPAImportInvestigationVehicles

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

posted by Jennifer Diaz January 19, 2017 0 comments

Screen Shot 2017-01-18 at 11.48.28 AMOn 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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FDA IssuesFoodFSMAImport

FSMA: Stay Compliant with DTL’s ‘PICTURE’!

posted by Jennifer Diaz January 12, 2017 1 Comment

FSMA todo listEach year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.
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Best PracticesCBPEventsFTAImportIPR, Trademarks and LogosSpeakingU.S.Customs

Don’t Gamble with Compliance

posted by Jennifer Diaz January 6, 2017 0 comments

massconversions Are you interested in e-Commerce? Have a desire to go to Vegas?

Diaz Trade Law founder Jennifer Diaz will be speaking at the upcoming Massconversions Live e-Commerce conference in Las Vegas, Nevada. Jennifer’s presentation will focus on the TOP 10 Tips to Comply with Customs When Buying Online. Attendees will, by the end of her presentation, know and understand the importance of:

• Tariff classification
• Customs valuation
• Country of origin marking
• Intellectual Property Rights (IPR) Protection and CBP Enforcement
• Free Trade Agreements (FTAs)

Attendees will also learn basic customs concepts and terms like:

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