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 On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two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.
From all of us at Diaz Trade Law, we are incredibly thankful and grateful for your support this year. Despite this ongoing pandemic, Diaz Trade Law still managed to save our clients MILLIONS of dollars in 2021. It is with great joy that we finish off 2021 filled with numerous achievements and accomplishments were humbled to share with you. We look forward to assisting you in what we envision will be a better and brighter 2022!
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.