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.

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

1. Why Pre-Compliance is a Must
2. Ongoing Hoverboard Concerns
3. Yet Another Reason to Record your Trademark or Copyright with U.S. Customs and Border Protection (CBP)
4. U.S. Customs - Your Personal Policeman at the Border
5. Learn About "The ABC's of Customs Seizures - Plus Top 10 Tips to Ensure Import Compliance" From the Expert!
6. ISF Penalties Have Officially Arrived: Self File and Self Police

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".

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

Each 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.

Don't Gamble with Compliance

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: