FDA Issues Archives - Page 19 of 32 - Customs & International Trade Law Firm

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

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. […]

By Jennifer Diaz|2018-09-06T15:06:14-04:00January 12, 2017|FDA Issues, Food, FSMA, U.S. Food and Drug Administration (FDA)|2 Comments

19 Antibacterial Soap Ingredients to be Banned by the FDA!

Co-authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law.

Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection.

Popular as antibacterial products may be, beginning September 2017, many of them may no longer be marketed as such, based on a Final Rule (78 FR 76444) issued by the U.S. Food & Drug Administration (FDA) on September 6, 2016. This Final Rule comes after several years of an FDA investigation into the effectiveness and potential hazards of antiseptic agents in personal care products. The most popular antiseptic agent in these products is triclosan, which, along with eighteen (18) other antiseptic agents under this Final Rule, is now banned when used for antibacterial purposes in hand and body washes. […]

By Jennifer Diaz|2022-07-07T11:50:26-04:00November 17, 2016|Customs Expert, FDA Issues, International Law, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Targets Vending Machine Operators

Co-Authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law.

Since April 2008, pursuant to New York City Health Code Section 81.50, all Starbucks (and many other restaurants) in New York City have been required to display the calories of each of the menu items. A subsequent study found that this mandatory calorie posting influenced consumers in NYC, causing average calories per transaction to drop by 6%. The study also found that calorie posting did not cause any significant change in Starbucks’ overall revenue.

Now, owners and operators of vending machines across the U.S. are next. Back in December of 2014, the Food and Drug Administration (FDA) issued a final rule entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”. This rule is codified at 21 CFR 101.8, and requires vending machine operators who own or operate twenty (20) or more vending machines, or who voluntarily register with FDA to be covered, to
declare calories for those vending machine foods for which the Nutrition Facts label cannot be examined before purchase or for which visible nutrition information is not otherwise provided at the point of purchase. According to the December 2014 final rule, covered vending machine operators must comply by December 1, 2016.

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By Jennifer Diaz|2022-07-07T11:44:26-04:00September 1, 2016|Best Practices, FDA Issues, Food, Labeling|0 Comments

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