FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective date of the Quality...more
The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents to be released this upcoming year....more
10/17/2025
/ 510(k) RTA ,
Artificial Intelligence ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Real World Evidence ,
Regulatory Agenda ,
Regulatory Oversight ,
Robotics
The U.S. Food and Drug Administration (FDA) recently announced a Request for Public Comment on the evaluation of devices that integrate artificial intelligence (AI), including generative AI (GenAI)-enabled technology. FDA's...more
10/9/2025
/ Artificial Intelligence ,
Comment Period ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Public Comment ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and quality systems. The...more
9/30/2025
/ Best Practices ,
Cloud Service Providers (CSPs) ,
Data Security ,
International Harmonization ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk-Based Approaches ,
Software
We are closely following the recent Section 232 investigation initiated by the U.S. Department of Commerce's Bureau of Industry and Security. A Section 232 tariff investigation is a formal process conducted by the U.S....more
9/29/2025
/ Bureau of Industry and Security (BIS) ,
Government Investigations ,
Healthcare ,
Imports ,
Life Sciences ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Section 232 ,
Suppliers ,
Supply Chain ,
Tariffs ,
U.S. Commerce Department ,
US Trade Policies
In today's volatile global economy, medical device companies are redrawing their supply chain maps. Disrupted by the COVID-19 pandemic, shaken by geopolitical tensions, and propelled by federal priorities that increasingly...more
9/29/2025
/ Country of Origin ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Manufacturing Hubs ,
Medical Devices ,
Mexico ,
National Security ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Reshoring ,
Suppliers ,
Supply Chain ,
Tariffs ,
US Trade Policies
The U.S. Food and Drug Administration (FDA) has issued two significant warning letters in recent months—one to SeniorLife Technologies Inc. and another to Whoop—that together mark a clear escalation in the agency's...more
9/19/2025
/ Artificial Intelligence ,
Digital Health ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Software ,
Mobile Apps ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Warning Letters
As we move through 2025, FDA medical device inspections are revealing a clear shift in regulatory posture under the current administration. While modernization and efficiency remain central themes, the FDA’s inspection...more
9/19/2025
/ 510(k) RTA ,
Artificial Intelligence ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Inspections ,
Investigations ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Warning Letters
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more
As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more
The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more
The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more
Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...more
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more
This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more
The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based agencies work to ensure public health and safety. Operating without a required license...more
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more
State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more
On February 6, 2025, the Trump Administration released published a Request for Information (RFI) on behalf of the White House Office of Science and Technology Policy (OSTP) concerning the development of an Artificial...more
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more