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Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

posted by Jennifer Diaz May 30, 2019 1 Comment

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Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

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FDA Issues Guidance Documents on Food Facility Registration

posted by Jennifer Diaz September 18, 2018 1 Comment

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 FDA

Constituent Update

August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).

One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration. Continue Reading

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Exporting 201 – Advanced Exporting Webinar 5/22 – RSVP Today!

posted by Jennifer Diaz May 7, 2018 0 comments

depositphotos_46947357-stock-illustration-book-now-stampWhether you are a new or experienced exporter, the next webinar is essential!

  • When do you get to hear from a Board Certified Expert on actual horror stories and when it’s in your best interest to file a Disclosure?

RSVP now to join our Exporting 201 webinar. And don’t forget to check out all of our upcoming webinars!

RSVP TODAY!

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Does Your Medical Device Have a Unique Device Identification (UDI)?

posted by Jennifer Diaz June 14, 2017 0 comments

We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement. Continue Reading

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

posted by Jennifer Diaz June 12, 2017 0 comments

Medical DevicesOne 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? Continue Reading

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

posted by Jennifer Diaz April 28, 2017 1 Comment

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 insigns 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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Medical Device Registration Made Easy!

posted by Jennifer Diaz January 27, 2017 3 Comments

Screen Shot 2017-01-26 at 1.40.53 PMThis 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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Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015

posted by Jennifer Diaz November 6, 2015 0 comments
Register Now
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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3 Part Compliance Seminar Series You DON’T Want to Miss!

posted by Jennifer Diaz August 24, 2015 0 comments
blog 29 pictureWe are excited to announce our upcoming 3 part seminar series on ImportingExporting, and FDA Compliance! Government and private speakers will participate.  
Each seminar will provide resources for new and experienced international trade
professionals including:

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Calling Medical Device Importers Attending U.S.’s TOP Medical Show, FIME

posted by Jennifer Diaz July 29, 2015 0 comments

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If you import medical devices into the U.S. (or want to), FIME is the trade show for you. Last year, FIME surveyed attendees and received feedback that 52,890 FIME attendees were interested in 25 categories of medical device products. FIME is the #1 Medical Show, and the #1 Medical Trade Fair – and takes place from August 5-7, in my home town, at the Miami Beach Convention Center. Since 2010, I have had the privilege to be a speaker at FIME and had some of the
largest groups of attendees to discuss compliance with the FDA, and how to resolve typical FDA and CBP issues.  

I’m thrilled to say I’m speaking again this year. My topic is “How to Effectively Resolve Typical U.S.
Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”. 

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