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 On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two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.
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.
Diaz Trade Law’s President, Jennifer Diaz and Associate Attorney, Denise Calle are enthusiastic to announce that another one of their articles, “PPE Imports During COVID-19,” was published by Bloomberg Law! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback!
You can read the article here, by clicking PPE Imports Article (where you’ll have the ability to access all of the great hyperlinks) you cannot click on below.
We’d love to hear your feedback!