Medical Devices Archives | Customs & International Trade Law Blog

Don’t Let FDA Target Your Medical Device Company

Did you know FDA has issued 1,569 enforcement actions against medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

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By Jennifer Diaz|2021-10-07T14:48:15-04:00August 10, 2021|COVID-19, Import, Import Alert, International Business, International Law, International Trade, Labeling, Medical Devices, PPE, Pre-compliance, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off

HELP US CELEBRATE 2018 SUCCESSES!

DTL saved clients MILLIONS of dollars in 2018, below we share some of success stories with you. We look forward to assisting you in 2019!

U.S. Customs & Border Protection (CBP)

Successfully assisted numerous importers in various seizure cases to assist in getting property returned, despite CBP claims merchandise was drug paraphernalia, counterfeit, etc.

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By Jennifer Diaz|2021-10-29T15:16:35-04:00December 26, 2018|Best Practices, Import, International Law, International Trade, U.S. Customs and Border Protection (CBP)|Comments Off

WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

One might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.

What is a Medical Device? […]

By Jennifer Diaz|2021-11-09T13:46:52-05:00June 12, 2017|Best Practices, Import, Medical Devices, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

FDA Launches New Webpage to Promote Use of Symbols in Medical Device Labeling

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

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By Jennifer Diaz|2022-07-06T15:45:03-04:00April 28, 2017|Best Practices, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|3 Comments

Medical Device Registration Made Easy!

This article 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|2021-11-09T13:54:48-05:00January 27, 2017|Export, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|4 Comments

Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015

Do you need to know the current issues affecting importing and exporting for international trade professionals? What about common compliance issues when importing food, cosmetics, and medical devices? If you answered yes, you will not want to miss the last of our three-part seminar series that will cover these topics and much more. Plus, members of supporting organizations, clients of Becker & Poliakoff, and future members and clients, will receive a discount! Here’s all the information about our upcoming seminar:

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By Jennifer Diaz|2022-07-06T15:13:43-04:00November 6, 2015|Best Practices, Cosmetics, Customs Broker, Food, FSMA, Import, Import Alert, Medical Devices, Speaking, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

FDA Discusses TOP Reasons for Detention of Goods

At today's Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA's Joint Team 488 - which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows...

By Jennifer Diaz|2021-11-10T14:22:59-05:00March 20, 2013|Best Practices, Cosmetics, Food, FSMA, Import, Import Alert, Medical Devices, U.S. Food and Drug Administration (FDA)|Comments Off

Jennifer Diaz Opens Medical Device Seminars at FIME

The worldwide medical community is converging on Miami Beach for the largest and most comprehensive trade show in the United States, featuring medical manufacturers from all over the globe. Attorney Jen Diaz will be presenting the first seminar "How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices" at the FIME Show at 10:00 AM on Wednesday, August 8, 2012.

By Jennifer Diaz|2019-10-22T01:57:09-04:00August 2, 2012|Medical Devices, Speaking|Comments Off

Medical Devices Seminar

On August 14, 2009, Peter Quinter and Jennifer Diaz will speak at the annual FIME conference taking place at the Miami Beach Convention Center. We will discuss "How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices."

By Jennifer Diaz|2009-08-06T15:27:18-04:00August 6, 2009|Food, Medical Devices|Comments Off