Insights on Medical Devices

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.

License Exception MED, published by the US Department of Commerce’s Bureau of Industry and Security (BIS) on April 25, authorizes the export, reexport, or in-country transfer of EAR99 “medical devices” to non-military hospitals but comes with new restrictions and due diligence requirements.

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.

The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy.

In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change.

FDA’s website allows you to determine if a particular COVID-19 test has been reviewed by the FDA.

On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus.

FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic.

The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the test.

On Friday, May 22, 2020, the USDA and FDA jointly released recommendations to address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industries.

“Testing, Testing, Testing” is the new mantra. The politicians and the press are full of the few reports of testing successes and the many reports of testing failures throughout the country and around the world.

On May 8, 2020, the FDA announced that it had authorized the first COVID-19 diagnostic test that can be used to collect saliva in the home.

What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China. 

The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and, as a result, those who might now have immunity, at least temporarily. Howev

On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic.

This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment (PPE) that pose supply challenges due to high demand.

As the United States begins to see positive signs that mitigation efforts such as stay-at-home orders and social distancing are working, the question of when people can return to work and resume normal activities is one of the most critical issues facing the country – and indeed the world. 

FDA continues at a relatively fast clip to issue policies intended to help solve a dire problem: the ongoing need to expand the availability of certain medical products in the US that are critical to addressing the COVID-19 pandemic.

This updates our prior Alert regarding the importation and distribution of respirators and other masks to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.

As part of its ongoing effort to address the critical shortage of Personal Protective Equipment (PPE) needed to address the COVID-19 pandemic, FDA has issued an Enforcement Policy to help expand the availability of surgical apparel for healthcare professionals, including gowns and gloves.

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for ventilators, accessories, and other respiratory devices.

Teva Pharmaceuticals filed suit against the United States Food and Drug Administration (FDA) alleging that its glatiramer (Copaxone) falls under the revised definition of a “biological product” and should be transitioned to the system established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.

FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand their use for healthcare professionals to monitor patients remotely during the COVID-19 pandemic.