Ariel Seeley at Morgan Lewis

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This...more

11/5/2025 / Cybersecurity , Department of Justice (DOJ) , Enforcement Actions , False Claims Act (FCA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , New Guidance , New Legislation , Popular , Regulatory Requirements , Risk Management

FDA’s Evolving Complete Response Letter Disclosure Practices: Impacts and Considerations

With the recent publication of numerous, previously unpublished complete response letters, coupled with its plans to increase these disclosures going forward, FDA has taken a significant step forward in its previously stated...more

10/9/2025 / Biotechnology , Data Privacy , Disclosure Requirements , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Personal Information , Pharmaceutical Industry , Regulatory Authority , Regulatory Oversight , Securities and Exchange Commission (SEC) , Trade Secrets , Transparency

Marketing Medical Devices: Navigating Increased FDA Scrutiny

With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC)...more

10/3/2025 / Advertising , Cease and Desist Orders , Department of Justice (DOJ) , Direct to Consumer Sales , Enforcement Actions , False Advertising , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Healthcare , Influencers , Life Sciences , Marketing , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Social Media

FDA Announces Crackdown on DTC Advertising: What It Means for Pharma and What Comes Next

The White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly...more

9/16/2025 / Advertising , Department of Health and Human Services (HHS) , Digital Media , Enforcement Priorities , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Healthcare , Influencers , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Rulemaking Process , Social Media , Trump Administration

Processed Food Industry in the Crosshairs: FDA and USDA’s Ultra-Processed Food Request for Information

Last week’s issuance of a request for information (RFI) in the Federal Register by the FDA and the US Department of Agriculture (USDA) marks the first step in the administration’s effort to address health concerns associated...more

7/31/2025 / Consumer Protection Laws , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Popular , Public Health , Regulatory Requirements , USDA , Warning Labels

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

7/7/2025 / Artificial Intelligence , Department of Health and Human Services (HHS) , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Rulemaking Process

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more

6/11/2025 / Algorithms , Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Regulatory Oversight , Regulatory Requirements

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

6/10/2025 / Coronavirus/COVID-19 , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Generic Drugs , Medical Devices , New Guidance , Public Health , Regulatory Reform , Rulemaking Process

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

6/4/2025 / Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

5/27/2025 / Algorithms , Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Digital Health , FDA Approval , Health Technology , Medical Devices , Medicare , Proposed Legislation , Reimbursements

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

4/22/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Oversight , Regulatory Requirements

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

4/10/2025 / Cybersecurity , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Hospitals , Manufacturers , Medical Devices , New Guidance , Regulatory Requirements , Risk Assessment , Risk Management

Ariel Seeley

Morgan Lewis

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