Angela Silva on Medical Devices

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6/4/2025 / Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory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As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures.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

FDA Issues Long-Awaited Diversity Action Plan Guidance

Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and...more

8/19/2024 / Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance

While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for...more

5/22/2024 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

FDA Finalizes Framework for Transitioning from COVID-Related Medical Devices EUA/Enforcement Discretion to Permanent Marketing...

The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing...more

4/14/2023 / Draft Guidance , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices

FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...more

1/19/2022 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry

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