Tag: FDA

A New Era for Medical Device Regulation: Inside FDA’s QMSR Transition

Medical device regulation is an imperative yet cumbersome process that spans throughout a product’s lifecycle, from initial development and premarket approval and ending with post-market surveillance. Since 1978, the FDA has steadily improved U.S.-centered regulations governing medical device manufacturing to ensure companies remain compliant with an array of evolving safety requirements. 

On February 2, 2026, the Food and Drug Administration (“FDA”) promulgated a new Quality Management System Regulation (“QMSR”) in 21 C.F.R. Part 820, which reflects a groundbreaking shift in medical device regulation. Abandoning the Quality System Regulation (“QSR”), the QMSR harmonizes domestic standards of medical device quality management with international standards established by the International Organization of Standardization (“ISO”). While the QMSR aligns with the foundational requirements under the ISO, it also contains “FDA-specific requirements” that yield various implications for companies entering the medical device space. 

One of the most prominent changes under the QMSR in its effort to align with ISO standards is the adoption of a risk-based inspection approach. Essentially, medical device inspections will now orbit around patients and users throughout a product’s lifecycle, making risk management paramount. Under this new model, FDA investigators will review medical device products “based on product-specific risks, complaint histories, prior compliance issues, and other risk indicators.” Additionally, FDA investigators can access company “audit reports, management review documentation, and supplier audit reports” to evaluate the company, its leadership, and its internal approaches to mitigating risk. 

Another key shift under the QMSR is the FDA’s emphasis on post-market surveillance, which works in-tandem with the risk-based inspection model. The heightened degree of oversight regarding post-market evaluation holds companies to more stringent expectations, as FDA investigators will now closely monitor recall trends, design changes, supplier conflicts, and ongoing compliance concerns. This robust escalation requires companies to move beyond managing risk-based decisions and instead show post-market responsiveness to field changes and various emerging risk factors.

Lastly, in response to rapid technological advancements, the FDA will also inspect “cyber devices” and other digital software installations. Specifically, the FDA seeks to verify that cyber devices have a sufficient structural design and maintain a requisite degree of security and threat management. Cyber devices and software will also be viewed from a patient-focused lens, and companies are encouraged to modernize internal technology throughout the manufacturing process. 

Ultimately, this regulatory paradigm shift, coupled with the recent increase in warning letters, signals an expansive pivot in medical device regulation. FDA’s new patient-centered requirements are sweeping, effectively requiring companies to implement a holistic approach to product development, active risk-management, and post-market review. The FDA’s position under the QMSR heavily emphasizes that quality radiates throughout a company and is perpetuated by effective management that oversees continuous risk-based decisions. FDA advises against treating quality as merely a “compliance exercise for inspection day.” Failure to adhere to new QMSR requirements poses substantial risks, including potential denial of product applications. 

In response to these instrumental changes, leading FDA regulatory attorneys advise medical device companies to continue evaluating their current manufacturing and development practices with a gap analysis (a corporate comparison of current practices and future goals) to ensure they are compliant with the new QMSR requirements. Companies should also consider scheduling pre-approval FDA inspections earlier to avoid discovering inadequacies late in the approval process, which can decrease investor confidence, derail market entry timelines, and even result in FDA’s denial of the application. In addition, companies are encouraged to collaborate with stakeholders, suppliers, and advisors to show a proactive quality culture and acknowledge FDA’s heightened risk-based analysis that demands more than only preparing for inspection day.

Biosecurity Catching Up to the Modern Era: A Look Into S.3741

Biotechnology is a rapidly evolving field, touching almost all parts of the human experience. The field has become a stronghold in the United States due to increased investment and a new multi-disciplinary approach to the developing research. Though these innovations are important for the future of disease prevention and the eradication of hunger and petrochemical dependence, it also leaves the door open to potential bioterrorism if these technologies get into the hands of bad actors. Currently, oversight for biosecurity in the US government is spread among multiple agencies without clear and streamlined protections and processes. 

On January 29th, 2026, senators Tom Cotton (R-Arkansas) and Amy Klobuchar (D-Minnesota) introduced the Biosecurity Modernization and Innovation Act, a bipartisan bill aimed at closing some of the gaps in current biosecurity procedures. The bill has three main elements: the biosecurity element, the sandbox element, and the streamlining element. 

The biosecurity element creates screening protocols and reporting requirements. The screening protocols are twofold: there are protocols for both DNA sequences and for customers. The protocols for sequences include creating lists of sequences that have potential for security concern, and updating and monitoring those sequences often. The protocols also require that each customer purchasing a sequence is properly vetted and screened before the sequence is given. The bill also creates safeguards for innovation, including expedited processing for institutions and exceptions for non-concerning sequences. The bill requires yearly reports to Congress and biyearly updates to standards. 

The sandbox element directly impacts efforts to create innovation. Sandboxes are “environment[s] featuring short-term trials of proposed tests so that [researchers] can evaluate new regulatory pathways and potential improvements to existing pathways.” They allow for safe and efficient environments for technologies to be tested. The goal of this element is to create secure testing for innovation, and to foster participation of nongovernmental experts in the research and regulation process. 

Finally, the streamlining element gets to the core of what biosecurity advocates have requested from the government. Science organizations, including the Federation of American Scientists and the Nuclear Threat Initiative have requested streamlined processes from the government because of the disjointed processes to protect sequences from getting into the hands of bad actors. The bill gives the White House 90 days after the law is enacted to assess the needs of biosecurity and identify gaps that need to be filled, followed by a period of implementation that includes further legislation or executive action if necessary. 

The bill in its current state is a good first step toward biosecurity regulation in the quickly changing market. The government is making an effort to create long-term fixes to a problem that has before only received short-term band-aids. Its goal is to shift the burden from the researchers to the government, as the burden on researchers has inhibited efficient developments. Proponents of the bill state that this legislation is a step in the right direction, but make it clear that it is only a step, and that there is a lot more change that needs to be made to meet the quickly changing biotechnology environment. There is some concern about the short time period that the White House and executive branch are provided to start making discoveries and changes, but stakeholders find that the timeline matches the urgency that the issue requires. 

It is obvious that this bill is the culmination of the leading senators listening to the requests of important stakeholders. It remains to be seen how this bill will fare in committee, but with bipartisan and stakeholder support, there is a sense of hope that this can kickstart rapid change that is urgently needed. 

Emerging SEC Disclosure Challenges in the Life Sciences Industry

Why is the life sciences sector an area of focus for the SEC? 

The United States Securities and Exchange Commission (“SEC”) is responsible for a pivotal aspect of regulatory oversight for publicly traded life sciences companies: monitoring public disclosures about interactions with the Federal Drug Administration (“FDA”). Pharmaceutical drugs, medical devices, and other life science products are often subject to the FDA regulatory approval process, where information about progress and development can greatly affect their market status and the price of a company’s stock. Thus, life sciences companies face substantial pressure to accurately disclose information about trial outcomes and approval status, as even unintentional misrepresentations and missteps can trigger SEC investigations. Therefore, the industry must balance communicating the clinical progress of their products with protecting confidential and proprietary information, as the SEC continuously monitors disclosures to prevent insider trading and fraud. 

What are life sciences companies required to disclose?

The primary regulation established by the SEC to enforce disclosures is known as the materiality standard, which requires the timely and complete disclosure of material information through annual (10-K), quarterly (10-Q), and current (8-K) reports. Typically, the SEC considers drugs, medical devices, and other product developments material to investors as they are prone to massive valuation swings based on clinical holds or failures for approval. Life sciences companies grapple with this uncertain standard while engaged in FDA dialogue because they must prudently determine what feedback from the agency should be conveyed to investors and the SEC. During the drug approval process, when there is consistent back and forth between a company and the FDA regarding a pending application, there is no duty to disclose ordinary course interactions if they do not involve significant material conclusions or risks. Thus, there is a fine line between choosing not to disclose immaterial issues in order to avoid investor panic and misrepresenting the product’s regulatory status to the federal government.

How is the reporting landscape shifting in the industry?

The life sciences industry can be unstable and unpredictable, and conflicts are often layered where co-investments, cross-fund participation, and compensation tied to portfolio milestones are involved. To ensure adequate disclosures, regulators tend to focus on valuation pressure points including assumptions around trial outcomes or FDA approval probabilities. Because life sciences companies are particularly susceptible to insider trading risk given the amount of material non-public information (MPNI) they possess, the SEC has recently intensified its focus on the transparency of these corporations. In order to manage the uptick in enforcement, life science companies are encouraged to adopt internal policies and include contract provisions to prevent trading on MPNI and remain objective in their disclosures about FDA feedback. More proactive and fulsome risk disclosures may help to insulate industry actors from SEC or shareholder scrutiny. False or misleading statements are prohibited by federal securities laws, so companies must be weary of their continuous oversight and keep pace with evolving disclosure requirements.

What are the emerging legal risks for corporations?

If the SEC concludes that a life sciences company submitted inaccurate or misleading disclosures, harsh consequences include substantial financial sanctions, the prohibition of individuals serving as company directors or officers, and, in extreme scenarios, criminal prosecution by the Department of Justice. The FDA itself is able to inform the SEC of securities violations and share nonpublic information with them regarding life science products, particularly if public health is at risk. Even though SEC enforcement trends have recently decreased overall, pharmaceutical, life sciences, and healthcare companies face increased enforcement activity, particularly due to the growing complexity of clinical data and industry share price movement. The Commission has expressed continued interest in cases indicative of overt fraud, false or misleading disclosures causing investor harm, and individual accountability for senior leaders of corporations. Overall, the higher selectivity of SEC actions heightens risk for public company executives, calling for robust internal and disclosure controls and transparent investor and SEC communications. 

Organ on a Chip – The Future of Drug Testing and Development

Organ chip technology is transforming modern research because it mimics personalized organ systems and will serve as an alternative to animal testing and other testing methods. The organ on a chip is the size of a coin, clear and flexible with a two-channel microfluidic chip separated by a cell-permeable membrane. The microfluidic chips mimic organ functions or states in the body. The cell-permeable membrane is thin and can be stretched by a vacuum to allow for cellular communication between microfluidic chips. A tissue-specific support layer covers the cell-permeable membrane to aid in tissue growth and maturation. Organ chips are grown in a small device that controls chip movement so it can properly demonstrate the functions of the body. 

The first organ on a chip was developed in the 2000s. It was designed to model excess fluid accumulation in diseased lungs. The organ chip mimicked the airways in the lungs and even made a similar “crackle” noise, a symptom in patients with diseased lungs. Following the development of the lung chip in 2010, fifteen more chips were developed after other organs and systems in the body and can even mimic diseases and genetic disorders in the body. Beyond human systems, organ chips have been developed to model dogs, rats, and mice. 

As opposed to traditional animal testing methods, organ on a chip provides information about a drug’s effect specifically on human cells. Organ on a chip technology is intended to accurately represent the body’s organs and functions on a small, simple to use device to support a faster way to test the impact of drugs and their doses on the body. The technology is capable of determining whether new drugs are safe by discovering early warning signs which helps researchers accurately understand disease effects on the body. This information and technological ability can lead to tailored treatments for individuals by providing researchers information on how specific people will respond to a drug. A “Patient-on-a-Chip” program is being developed to provide patients with tailored treatments to make care safer and more effective. Scientists collect blood or skin cell samples that are converted into special stem cells and then created into organ cells containing the person’s genetics. Scientists can test drugs on the organ chips and see how the specific person would respond before the person takes the medicine.

Since this is a novel technology, regulatory agencies can be less likely to accept the data from an organ chip and may require additional information to confirm the accuracy of the findings. However, the Food and Drug Administration (FDA) has conveyed interest in organ chips through working with pharmaceutical industries to help further develop the technology. In April 2025, FDA announced that the administration would be phasing out animal testing in replacement of human based models, such as organ chips. To implement this change, FDA will be updating policy and regulations to allow for new methods during drug testing. In doing so,  FDA expects that this will accelerate drug testing and reveal human-specific side effects that may not be revealed during animal studies. The Human Liver-Chip was recently accepted into FDA’s Innovative Science and Technology for Advancing New Drugs pilot program, which allows for the use of drug development tools that do not meet regulatory standards but provide supportive data. This program is intended to aid in the acceptance of new drug development tools. 

NASA has also expressed interest in the technology and plans to send organ chips to the Moon to study effects of gravity and space radiation. Microgravity from space travel can make the human body age at an accelerated rate. Researchers developed a program called Tissue Chips in Space 2.0 that sends organ chips to the International Space Station with the goal of studying the effects of microgravity to understand how diseases develop, test treatments, and improve astronaut health during space travel. 

Compounded GLP-1s: Filling a Medical Need But Posing What Dangers?

There are many drugs on the market created in a myriad of ways with some manufacturing processes less regulated, and therefore more dangerous, than others. One such method is called human drug compounding. Compounding occurs when a licensed physician or person under the supervision of a licensed pharmacist combines ingredients to form a medication designed for a specific patient. Compounded drugs can be incredibly important: they fill the gap for patients requiring specific strengths or dosages not available on the commercial market, they can remove allergens from drugs for patients with allergies, and they can change the form of the medication for patients that may have unique needs. It is also possible to create compound versions of the drugs on the FDA’s drug shortages list if the drug meets certain requirements. 

However, compounded drugs also come with a great risk: they are not FDA-approved. The Food and Drug Administration (FDA) is tasked with protecting the public health by approving drugs based on safety, efficacy, and security standards. The FDA has a robust drug approval process through which most drugs in the U.S. must pass, but compounded drugs are not subject to this process. This means that a compounded drug may not meet quality or safety standards as a traditional commercially marketed drug would.

One recent area where compounded drugs have become increasingly popular: GLP-1 drugs. A GLP-1, or glucagon-like peptide-1, is a hormone that is naturally produced in the body. Companies have figured out how to develop GLP-1s into drugs, initially to treat type 2 diabetes and more recently for weight management.

In a statement by the FDA released on February 6, 2026, the FDA announced it intended to take “decisive steps to restrict” the active ingredients of GLP-1s that are intended to be used in non-FDA approved compounded drugs in order to “safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy,” as the selling of non-FDA approved drugs is a violation of the Federal Food, Drug, and Cosmetic Act. The statement also addressed misleading advertising and marketing of companies claiming that their non-FDA approved compounded drugs were simply generic versions of FDA-approved drugs.

Hims & Hers, referenced in the letter, has been in the headlines recently. Novo Nordisk, maker of the Wegovy pill and injections, has filed a lawsuit against Hims & Hers, a telehealth provider, for marketing compounded versions of its drugs, claiming patent infringement. Recent statements by Novo Nordisk’s general counsel for global legal, IP, and security called into question the safety and risks associated with Hims & Hers products, referring to the lack of FDA regulation for compounded drugs. This is not the first legal and regulatory issue faced by a GLP-1 manufacturer. In 2024, Eli Lilly’s weight loss drugs Zepbound and Mounjaro had their active ingredient tirzepatide regularly compounded before the FDA took it off the drug shortages list. The problems are likely just beginning. Between 2019 and 2024, Medicare Part D claims increased from 4.8 million to 21.8 million for GLP-1s. In addition to Novo Nordisk’s patent suit, there is also ongoing multidistrict litigation against Novo Nordisk and Eli Lilly by patients alleging loss of eyesight from their weight loss drugs. With the explosion of GLP-1s, it is likely that more issues will arise.

Overcompensation?: The FDA Nixes Boxed Warnings for MHT Drugs

The U.S. Food and Drug Administration (FDA) recently removed boxed warnings for six menopausal hormone therapy treatments (MHTs), drugs that reduce the uncomfortable side effects of reduced estrogen levels. These are the FDA’s highest level of warnings that appear on drug packaging in bold print and warn users of serious adverse reactions or important dosing restrictions. For MHT, the boxed warning informs consumers that MHT increases the risk of cardiovascular disease, breast cancer, and dementia.

Although this may look at first glance like another one of the current administration’s attempts to flip food and drug law on its head, a closer look at the scientific findings that prompted the boxed warning indicates it’s not so simple. Originally, the FDA mandated boxed warnings for MHT drugs after the Women’s Health Initiative (WHI) conducted a study in 2002, finding coronary heart disease and invasive breast cancer as primary adverse outcomes based on largely observational data. After the warning was implemented, usage dropped 22% for menopausal women from 1999 to 2020.

However, the safety and long-term risks of MHT have been debated by scientists, particularly because of the WHI study’s controversial design. The study had two main design flaws: it included women with an average age of 63, and the study tested synthetic hormones that are not the same as MHT drugs on the market today. The average age of participants was problematic because women generally experience menopause around age 51.5, but women around 63 years old are more likely to have preexisting cardiovascular issues. Furthermore, the use of synthetic hormones in this study means the adverse health outcomes are not necessarily attributable to the MHT treatments currently on the market. Additionally, modern MHT treatments use lower doses of estrogen and can be delivered through the skin may further reduce the likelihood of adverse events.

FDA panelists were urging the removal of boxed warnings specifically for vaginal estrogen because it poses the lowest risk of adverse effects. When this route of MHT treatment is taken, less estrogen is absorbed in the patient’s bloodstream, which lowers the risk of blood clots, stroke, and cancer. However, the FDA ultimately chose to remove boxed warnings for all estrogen-containing MHT treatments.

Under the Federal Food, Drug and Cosmetic Act, drug labeling must reflect current and accurate science-based evidence without misleading consumers. There is a risk that removing these warnings about increased risks of cardiovascular disease, breast cancer, and dementia for all estrogen-containing MHT treatments was premature, despite the shortcomings of the WHI study. If labels understate risks of MHT treatment, companies may risk facing claims of misbranding drugs under the Act, even though the FDA no longer requires the boxed warning for six current MHT drugs.

Women deserve a better solution than an outdated, poorly designed study for MHT drugs. Instead of risking liability or debating whether the WHI study is accurate enough to make the FDA require boxed warnings about serious adverse effects, the government should provide a grant for a new study on MHT drugs in menopausal women with a younger average age than the previous study.