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 On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two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.
Weaknesses in the Public Health Industrial Base
Critical technology shortages have been a focus of President Trump’s trade and industrial policies. In an October 2020 report on the topic, the Trump administration identified medical and public health technologies as a key sector in which the U.S. needs to do more to protect and cultivate its technological advantage. According to some analysts, the COVID-19 pandemic has demonstrated that the United States’ public health industrial base is overly reliant on imports for critical medical and pharmaceutical needs. The first few months of the pandemic were characterized by significant shortages of key medical supplies such as ventilators and personal protective equipment. However, this overreliance pre-dated the pandemic. For example, in October 2019, the U.S. Food and Drug Administration (“FDA”) estimated that the United States accounts for only 28 percent of global active pharmaceutical ingredient (“API”) manufacturing facilities and that 80 percent of APIs consumed in the United States are produced abroad, the majority in China and India.
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!
On March 18, 2020, President Trump issued an Executive Order (EO) focused on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19. This EO stems from authority granted under the Defense Production Act of 1950 (DPA) and seeks to “ensure our healthcare system is able to surge capacity and capability to respond to the spread of COVID-19.”