Brandon von Kriegelstein

Katten Muchin Rosenman LLP

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Latest Posts › Regulatory Requirements

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FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more

7/1/2025 / China , Clinical Trials , Data Privacy , Export Controls , Food and Drug Administration (FDA) , Genetic Materials , National Security , Personal Data , Regulatory Requirements , Sensitive Personal Information

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

6/30/2025 / Comment Period , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Proposed Rules , Regulatory Oversight , Regulatory Requirements , Supply Chain

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more

5/15/2025 / Compliance , Data Privacy , Enforcement , Final Rules , Health Insurance Portability and Accountability Act (HIPAA) , Healthcare , New Regulations , Patient Privacy Rights , Penalties , Regulatory Requirements

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