FDA Regulatory

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because a company advertises the product for wellness and lifestyle purposes. The advisory action also indicates that FDA’s Center for Devices and Radiological Health (CDRH) remains steadfast in its enforcement of device regulations despite ongoing changes in other centers and throughout the agency. 

The July 2025 edition of FDA in Flux highlights five significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

Of Counsel Bridgette Keller is joined by Joanne Hawana, Ben Zegarelli, and John Daley, as they offer advice for navigating communications with the FDA.

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology, in the Eastern District of Texas to determine whether the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits the agency to regulate laboratory developed tests (LDTs) is a complete victory for clinical laboratories. The U.S. district judge’s decision, issued on March 31, 2025, vacated the May 2024 final rule through which FDA sought to specify that LDTs are agency-regulated in vitro diagnostic products (IVDs) and to describe a plan for phasing-in enforcement of existing medical device regulations for such products over four years (see our previous posts on the LDT final rule here and here). In adopting the plaintiffs’ arguments wholesale, however, the judge created some incongruities in the relevant regulatory frameworks, as well as several quandaries for FDA and the clinical laboratory industry going forward. These inconsistencies could have greater consequences down the road if the Trump administration decides not to appeal the ruling.

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase out the agency’s historical approach of enforcement discretion towards such tests (see here, here, here, and here). However, one infrequently considered regulatory compliance issue for LDTs is their reliance on separate specimen collection devices or convenience kits. All LDTs require the use of some form of biological specimen, such as blood or saliva, which may be collected by health care professionals in a clinical setting or by consumers in their homes before being submitted to a laboratory for testing. 

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The National Strategy called for creating more accessible food labeling practices to empower consumers to make healthier choices, among other laudable public health-focused goals. Prior to the January 2025 transition from the Biden to the Trump administration, the Food and Drug Administration (FDA) took concrete steps to address this particular National Strategy priority through both formal rulemaking and informal guidance. This blog post summarizes FDA's actions at the end of the Biden administration intended to modernize food labeling practices and move them forward in today’s more consumer-focused marketplace.   

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice” (the Workshop). Although the individual presentations and panel discussions throughout the Workshop covered a range of topics and raised a number of interesting questions and hypotheticals, the panelists did not draw any specific conclusions or reach any kind of consensus about next steps to address the critical issues. Even so, the panelists provided some crucial insights that companies and regulators must grapple with in the context of expanding use cases for AI in human research and creating rules governing such uses.

In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia, UC Berkeley, and Michigan State that evaluated the presence of metals in different tampons. The research team evaluated 60 samples of tampons, representing 30 unique products from 24 different brands, for the presence of 16 different metals. The researchers found that all the tampons evaluated contained measurable concentrations of each of the 16 metals, including toxic metals such as lead, arsenic, and zinc.

Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS). As summarized in this handy Mintz/ML Strategies timeline of the actions set forth in President Biden’s AI executive order, DHHS has a mandate to “develop a strategy for regulating the use of AI in the drug development process” and a deadline of October 29, 2024 to meet that obligation. Notably, earlier this year DHHS announced a functional reorganization within the department that included creating the position of Chief AI Officer in response to the presidential order.

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and breakthrough therapy/breakthrough device designation programs. These designation programs follow a typical paradigm – (1) a product developer demonstrates to FDA that its candidate meets certain qualifying criteria; (2) FDA grants the relevant designation to the product candidate in question; and (3) the product developer then benefits from an increased frequency of interactions with the agency during continued development of the product and/or a valuable advantage that’s secured upon the product’s future marketing authorization (e.g., orphan exclusivity or a priority review voucher). 

Read about the Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) joint workshop in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.

On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the Draft Guidance), for public review and comment. The Draft Guidance was issued pursuant to a directive from Congress in the Food and Drug Omnibus Reform Act (FDORA), signed into law in December 2022, which required FDA to issue or update guidance on diversity action plans that sponsors submit for certain clinical studies of investigational drugs and medical devices. The Draft Guidance also serves to update guidance that FDA previously issued on the topic in April 2022.

Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed policies for continuing limited enforcement discretion for certain types of LDTs have been thoroughly described and dissected (including by us in our previous post), it’s high time to dig into FDA’s perspectives on the comments it received on the proposed rule. 

Last month, the National Academies of Science, Engineering, and Medicine (“NASEM”) issued a report discussing the inclusion of pregnant and lactating people in clinical research and the health impacts of inadequate data from research involving this subpopulation. Titled “Advancing Clinical Research with Pregnant and Lactating Persons: Overcoming Real and Perceived Liability Risks,” the report came as a response to Congress calling upon NASEM to examine the real and perceived prevalence of legal liability resulting from including these research subjects in clinical trials. Overall, the report concluded that legal liability for including pregnant and lactating persons in research is very limited, but that perceptions of potential liability and a lack of explicit guidance for including this population safely have created real barriers to their inclusion.  In response, the report provides recommended actions for Congress, the Food and Drug Administration (“FDA”), the National Institutes of Health (“NIH”), and the Office of Human Research Protections (“OHRP”) to take to enhance the inclusion of this population in clinical trials, thereby enhancing data around the safety and efficacy of approved drug products for pregnant and lactating persons.  Study sponsors and institutions conducting research should continue to monitor developments in this area, including guidance from FDA.

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding down its historical enforcement discretion posture for LDTs. But FDA’s crusade is far from over. It will have much to do to implement the four-year phase-out period described in the final rule and those efforts may be delayed by litigation seeking to enjoin implementation of the rule altogether. While we wait for the litigation shoe to drop, let’s take a look at what the final rule says and the changes FDA made in these highly significant policy decisions since the Notice of Proposed Rulemaking was published on October 3, 2023 (see our previous posts on the NPRM here and here).

In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical devices and include “reagents, instruments, and systems intended for use in diagnosis, including determining the state of health, through the collection, preparation, and examination of specimens taken from the human body.” Unlike human drug and non-IVD device products, which generally must be authorized for a specific medical use prior to commercialization, IVD products may be sold for certain scientific research studies without FDA authorization, but such IVD products may not be sold for clinical diagnostic use.