Medical Device Archives | Customs & International Trade Law Blog

Draft Guidance on Medical Device Transition Period

In response to the COVID-19 Pandemic, the FDA took unprecedented action in transforming its enforcement because of the declaration of a Public Health Emergency while also issuing, and continuing, Emergency Use Authorizations. These governmental actions facilitated and increased the importation of necessary medical devices needed to combat the pandemic here in the United States. And now as the U.S. relaxes its pandemic protocol, the FDA is exploring the best way to have medical devices transition back to pre-pandemic regulations and protocol. On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. And to provide further assistance, the FDA hosted a webinar “Draft Guidances on Transition Plans for COVID-19 Related Medical Devices” providing further explanations to the trade community on what can be expected from the proposed transition plans.

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By Jennifer Diaz|2022-03-10T11:56:55-05:00March 15, 2022|COVID-19, Import, Medical Devices, PPE, U.S. Food and Drug Administration (FDA)|Comments Off

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

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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By Jennifer Diaz|2021-10-29T14:51:05-04:00May 30, 2019|Customs Expert, Import, Import Alert, International Trade, Medical Devices, U.S. Food and Drug Administration (FDA)|1 Comment

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

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. […]

By Jennifer Diaz|2022-07-06T15:49:23-04:00June 14, 2017|Best Practices, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|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

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

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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By Jennifer Diaz|2022-07-06T15:03:55-04:00July 29, 2015|Best Practices, Medical Devices, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off

Jennifer Diaz Teaches Two Medical Device Seminars at FIME

I’m pleased to be back for my fourth year teaching at FIME! For those of you that don’t know, FIME was rated the #1 medical show in the USA by Successful Meetings Magazine. FIME runs from August 6-8, 2014 at the Miami Beach Convention Center. You still have limited time to register to attend the conference and my seminars! […]

By Jennifer Diaz|2022-07-06T14:12:42-04:00August 1, 2014|Best Practices, Import Alert, Medical Devices, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off