Insights

Despite other sweeping changes to the federal government under the Trump administration, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed under former President Biden, remains good law. Below, we report on recent trends in FDA’s implementation and enforcement of MoCRA in the early months of Trump’s presidency.

On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.

A warning letter posted by the Food and Drug Administration (FDA) on June 18, 2024 offers a first glimpse into how FDA may enforce its new regulatory scheme for products that fall within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)’s purview. While MoCRA was enacted in December 2022 and many of its provisions became enforceable on December 29, 2023, until now, many have wondered how FDA will exercise its new enforcement powers.

On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health equity. In other words, FDA intends to specifically consider whether a device may provide for more effective treatment or diagnosis in populations impacted by health and/or health care disparities when determining eligibility for breakthrough status.

On September 28, 2022, the Food and Drug Administration (FDA) issued Clinical Decision Support Software final guidance. The guidance clarifies the agency’s scope of oversight and regulation of clinical decision support software based on the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also describes the criteria used to assess whether software functions do not meet the definition of a device.

The U.S. Food and Drug Administration (FDA) has again postponed the enforcement of certain requirements under the Drug Supply Chain Security Act (DSCSA), this time by three years. 

On October 7, 2020, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Battelle Memorial Institute (“Battelle”) for failing to adhere to Emergency Use Authorization (“EUA”) requirements for its N95 mask decontamination units. Battelle’s decontamination system, designed to sanitize N95 masks for healthcare professionals and thereby mitigate the shortage of N95 masks, was granted an EUA on March 28, 2020.

In March, 2020, the U.S. Food and Drug Administration (“FDA”) announced that the Agency would temporarily halt domestic facility inspections not deemed “mission-critical,” citing health concerns related to the COVID-19 pandemic. On July 10th, FDA announced its plans to resume domestic on-site facility inspections during the week of July 20th. 

On May 8, 2020 the U.S. Food and Drug Administration (“FDA”) shared a checklist of best practices for re-opening retail food establishments (including restaurants) during the COVID-19 pandemic. According to FDA, this checklist establishes key food safety practices, but is not an exhaustive list. FDA recommends that retail food establishments work with local health and regulatory authorities to discuss requirements for safely re-opening.

At the outset of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) barred the importation of various personal protective equipment (PPE) from abroad – particularly from China. However, in response to PPE shortages caused by the crisis, FDA changed course. As noted in a previous alert, on April 3, 2020, the Agency issued an Emergency Use Authorization (EUA) permitting the importation of non-NIOSH approved filtering face-piece respirators (respirators) manufactured in China, including KN95 masks. The April 3 EUA allowed dozens of manufacturers of masks made in China to begin importing and distributing their products as respirators within the U.S. However, on May 7, 2020, the FDA yet again changed course and revised the April 3, 2020 EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revoke authorization for over 50 Chinese manufacturers to market non-NIOSH approved face masks as respirators under the EUA.  

EDIT The U.S. Food and Drug Administration (FDA) walked back its policy that allowed COVID-19 antibody test kits to enter the market without agency review. In its original March 16 Final Guidance, FDA allowed commercial manufacturers to market and sell antibody test kits after internally validating their own products and notifying FDA. The Agency did not require emergency use authorization (EUA) as it did with PCR (molecular) testing, though seeking an EUA was “encouraged.”