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.
Diaz Trade Law’s President, Jennifer Diaz, and Associate Attorney, Sharath Patil, are enthusiastic to announce that our article, “COVID-19’S IMPACT ON 2020 TRADE FLOWS” was published by the Customs and International Trade Bar Association (CITBA) in its Spring 2021 newsletter. Below is the article for your reading pleasure.
On March 10, 2021, via Federal Register Notice ( 86 FR 13785), the United States Trade Representative (USTR) announced that 99 medical product exclusions will be extended from March 31, 2021, to September 30, 2021. This action extends a previous USTR action which extended these exclusions from December 31, 2020, to March 31, 2020 (85 FR 85831). […]
Background on Regulatory Review
U.S. federal laws come from a wide array of sources. They are generally organized under the following order of authority: 1) the U.S. constitution, 2) statutes passed by Congress, 3) treaties ratified by Congress, 4) case law, 5) executive orders, 6) regulations, and 7) agency guidance. After Congress has provided a federal agency with a policy mandate, an agency is empowered to promulgate regulations to provide detailed and binding rules on those matters.
For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.
On December 29, 2020, the Office of the United States Trade Representative (“USTR”) announced long-awaited extensions to a limited set of previously granted exclusions (for COVID-related products), that were set to expire on December 31, 2020. Meanwhile, importers across non-COVID industries are continuing to await guidance on their tariff exclusion extensions that are set to expire on December 31, 2020.
During the weeklong series of 10 informative webinars on trade regulations, we heard TOP TIPs from numerous federal agencies, including U.S. Customs & Border Protection (CBP), U.S. Food and Drug Administration (FDA)’s Division of Southeast Imports, Miami’s CBP Fines, Penalties & Forfeitures (FP&F) Office, Miami CTPAT Field Office and more! Each webinar was produced to assist importers and exporters understand compliance and hot issues. Below are summaries of two webinars – FDA Import Operations Associated with COVID-19 Efforts and CTPAT – State of the Program / Minimum Security Criteria Updates:
In light of COVID-19, on May 19, 2020, the Trump Administration issued a new Executive Order (EO) entitled, “Regulatory Relief to Support Economic Recovery” directing all federal agencies to promote economic recovery through non-regulatory action. Importers, exporters, and other businesses under the jurisdiction of one of the 42 plus federal agencies that have pending federal enforcement actions should consider the regulatory reform mandated by the EO.