U.S. and China Reach ‘Phase 1 Deal’

 Today, President Trump and the Chinese government announced a “Phase 1 Deal” and suspended the proposed increase in tariffs for products (on Lists 1, 2, and 3) that were set to begin on October 15. The scheduled tariff was set to increase from 25 to 30 percent on $250 billion worth of Chinese imports. In exchange, the Chinese government will buy $40-50 billion worth of American agricultural goods, and the agreement will include terms on both intellectual property rights and financial services.

Trump Administration Tightens Cuba’s Sanctions Program

Since June 2017, we have been anxiously awaiting changes to the Cuba sanctions program since President Trump signed an executive order and emphatically stated that his administration would tighten loose regulations established under the Obama Administration.

On November 8, 2017, the U.S. Department of the Treasury stated,

• “We have strengthened our Cuba policies to channel economic activity away from the Cuban military and to encourage the government to move toward greater political and economic freedom for the Cuban people”

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

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.

Ultimately a Device Manufacture has three options to choose from:

1. Do not use symbols
2. Use symbols with adjacent explanatory text, or
3. Use stand-alone symbols

What are “stand-alone symbols”?

• Symbols established in a standard developed by a standards development organization (SDO).
• FDA stress that “it’s critical that symbols on medical devices are understood by the individuals who use them.”
• FDA provides the example where manufacturers of sterile syringes could opt to use the symbol for “do not reuse” on a syringe package without adding the actual words “do not reuse” to the package.

What is required to qualify for use of “stand-alone symbols”?

• Under the final rule there are two possibilities to permit a medical device label to carry “stand-alone symbols” without adjacent explanatory text.

1. As long as the standard symbol is recognized by FDA under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(c)) and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, OR

2. If the symbol is not included in a standard recognized by FDA under section 514(c) or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act (21 U.S.C. 352(c)) and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard.

• In either case, the symbol must be explained in a symbols glossary that is included in the labeling for the medical device and the use of symbols must also comply with other applicable labeling requirements in the FD&C Act.

Who benefits from the Use of Symbols in Labeling Final Rule?

• Device Manufacturers
• Importers
• International trade community

Manufacturers or Importers who have questions about implementing the Symbols final rule are encouraged to contact our office at info@diaztradelaw.com or 305-456-3830.

More information is available at:

Medical Device Registration Made Easy!

Frequently Asked Questions

TPP: Dead or Alive?

Are you wondering whether, given President-elect Trump’s recent promise to abandon the agreement on his first day in office, the Trans-Pacific Partnership (“TPP”) is even going to happen? Are you interested in knowing what all the buzz is about the TPP? Would the TPP open up new business opportunities for your small- to medium-sized business in Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam? If you want to know more, then this FREE webinar is for you!

Top Five Reasons to Participate:

1. Gain insight into the nuts and bolts of how goods and services are exported from the U.S. into TPP countries.
2. Discover which elements of the TPP can help small- to medium sized U.S. companies save time, reduce costs, and improve certainty in TPP markets.
3. Hear from government officials what lies ahead with respect to the approval and entry into force of the TPP.
4. Take advantage of the opportunity to ask questions to and receive answers from TPP experts in real time (including whether or not they believe the TPP has a fighting chance).
5. Develop new contacts within the U.S. Commercial Service.

CBP EAST COAST Trade Symposium (#ECTS2016) Dec 1-2, 2016!

The CBP East Coast Trade Symposium theme is "Trade’s Impact on American Health, Safety and Economic Prosperity” and will take place from December 1-2, 2016, at the Hyatt Regency Crystal City in, Arlington, Virginia.

Our top 5 reasons to attend including an invite to a premier networking event are below!

Five Day TRADE Conference in Fort Lauderdale

Whether you’re a new business that wants to connect with import and export experts, or an existing business that wants to expand its activity across the globe, you do not want to miss the Florida International Trade & Cultural Expo (“FITCE”).

FITCE is a five-day event that is held October 12^th to 16^th at the Greater Fort Lauderdale Broward County Convention Center. World leaders, high level networking, business opportunities and expert panelists are just some of the reasons to attend FITCE.