July 2015

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 CenterSince 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”.

My seminar will take place on August 5, 2015, at 10:00 am (EST) in Room D232.

To entice you to attend, here’s a snapshot of the agenda:

  • Medical Device Basics
  • FDA Laws/Regulations
  • FDA Import Process
  • What You Need to Know to Import
  • How to Work Best to Expedite Your Shipments with a Customs Broker
  • FDA Notices of Action 
  • FDA Detention and Refusal Process
  • Import Alerts
  • Detention Without Physical […]

IS YOUR COSMETIC PRODUCT REALLY A DRUG?

In Junealone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.

The two main reasons the FDA cited in refusing entry of cosmetic products were:

  1. The products were “misbranded” (lack of adequate directions for use, nutrient content and/or health claims, anti-ageing labeling claims rendering the product a drug; or
  2. The products were “adulterated” (unsafe addition of a color additive).
Definition of a Cosmetic vs. Drug
Misbranding may come down to whether the FDA believes the product is a drug (which is often based on the products intended use, and labeling claims). It is therefore important to know the difference in the way FDA defines cosmetics and drug products, to ensure you label your products correctly.
A product designed for “cleansing beautifying, promoting attractiveness, or altering the appearance,” is generally defined as a cosmeticby the FDA.
A drugon the other hand, is as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.”
Why Cosmetic Products will be Refused by the FDA
One prevalent reason the FDA refuses cosmetic products is because of the claims cosmetic products makes rendering the product a “drug”. A health claim is one example of a type of claim, specifically it is a claim that the product affects the structure and or function of the human body. If your product makes a […]

Embassies and Island Wide Wi-Fi by July in Cuba

President Barack Obama announcedWednesday that the U.S. and Cuba will now reestablish diplomatic ties and reopen embassies in their respective capitals. The announcement comes just one month after the Secretary of State removed Cuba from the State Sponsor of Terrorism list. Although it would take an act of Congress to lift the trade embargo, reopening embassies is another brick in the foundation of normalizing trade relations. With the new embassies opening in July, there will be greater contact between the US and the Cuban people which will ultimately lead to a change in the US’s attitude towards the trade embargo.

A new US embassy is not the only thing coming to Cuba in July. Cuba’s state-run telecommunications company is planning on opening a network of Wi-Fihotspots that spans the entire island. They also plan on cutting the price of hourly access in half to $2. However, even though costs are less and there will be more Wi-Fi hotspots, the internet […]
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