Author: Mikayla Oko

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.

DTC Advertising Under Fire: A Turning Point for Drug Promotion?

The Trump Administration has taken assertive steps to rectify the overmedicalization of American citizens by increasing oversight of Direct-to-Consumer (“DTC”) prescription drug advertising. Specifically, President Trump delegated authority to the Food and Drug Administration (“FDA”) to implement stringent regulations to ensure patients receive balanced information. The Administration has emphasized that DTC advertisements have become increasingly misleading by omitting critical risk information, glamorizing the use of prescription medication, and deterring patients from cheaper or healthier alternatives.

On September 9, 2025, President Trump released an Executive Memorandum that underscored the prominence of deceptive DTC advertisements and the necessity for stricter regulation. The memorandum authorized the FDA and the Department of Health and Human Services to “regulate prescription drug advertising” by ensuring compliance with the principles of transparency and accuracy. President Trump additionally commanded the Commissioner of Food and Drugs to enforce the Federal Food, Drugs, and Cosmetics Act (“FDCA”) in connection with DTC advertising in the pharmaceutical space.

The Administration has pursued three key strategies to regulate DTC advertisements. Their approach includes (1) issuing warning letters to pharmaceutical companies, (2) reforming the adequate provision rule, and (3) restricting social media advertisements. Experts anticipate an increase in agency activity in the coming months.

Following President Trump’s memorandum, the FDA has released over 100 warning or untitled letters to various pharmaceutical companies, telehealth providers, and online pharmacies to target deceptive advertising practices. On September 16, 2025, the agency issued over 60 warning letters citing alleged violations of the FDCA. The violations primarily involved minimizing risks or side effects and publishing misleading content about medications. In light of this action, Alnylam Pharmaceuticals Inc. removed a DTC advertisement for its new heart medication, Amvuttra. The FDA alleged that the advertisement, which broadcast patients being active, was misleading because it indicated that patients with heart disease “can be carefree.” While President Trump’s initiative may reduce faulty advertisements, it may also limit patients’ access to information on transformative medications. However, these are merely pre-enforcement measures, and actual enforcement will possibly require the Department of Justice to intervene on behalf of the FDA.

The FDA is additionally establishing a regulatory framework to “close the ‘adequate provision’ loophole created in 1997,” which allows pharmaceutical companies to “conceal critical safety risks” in their DTC advertisements. Before the adoption of the adequate provision rule, DTC advertisements were obligated to include full boxed warnings and clearly state all risks. Further, in the 1990s, over 130 enforcement letters were issued annually to ensure compliance. After 1997, pharmaceutical companies circumvented these rigorous requirements due to the ease of restrictions, which permitted them to only include the most prevalent risks. This led to a profound increase in DTC advertisements, and in 2024, pharmaceutical companies spent $10.8 billion on advertising. From 1997 to 2016, there was a 460% increase in DTC advertisement spending.

Pharmaceutical companies have used the rise of social media to expand DTC advertising. However, according to the FDA, 88% of top-selling drug advertisements on social media allegedly failed to comply with the agency’s requirements of balanced information. Phase three of the Administration’s reform targets influencer partnerships, sponsored advertisements, and AI-generated content.

While the Trump Administration has illuminated the negative effects of DTC advertising, it is vital also to consider positive factors. The increase in patient exposure to drug advertisements provides crucial information about possible treatments or relief, and allows patients to make inquiries with their doctors. Additionally, DTC advertisements permit individuals to stay informed about pioneering developments in the pharmaceutical industry. With heightened awareness, the word-of-mouth spread of positive experiences can help inform others about possible treatment avenues.

President Trump’s DTC advertisement restriction is likely to be met with legal ramifications. Legal action to challenge the paradigm shift would plausibly be focused on First Amendment and commercial free speech rights. A 1980 Supreme Court case, Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, established a four-part test to evaluate the constitutionality of regulation. Essentially, Trump’s administration would have to affirm that their regulations would strictly benefit public health—yet pharmaceutical companies could adequately counter-argue using the aforementioned positive factors. To efficiently navigate this evolving climate, pharmaceutical companies and the government should collaborate on policies going forward.