Jonathan Trinh

Wilson Sonsini Goodrich & Rosati

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Latest Posts › Medical Devices

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FDA’s LDT Final Rule Rejected by Federal District Court in Texas

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for...more

4/4/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Judicial Review , Medical Devices , Regulatory Authority , Statutory Interpretation , Vacated

The Life Sciences Report – January 2025

This latest edition features an interview with retiring longtime Wilson Sonsini IP partner Vern Norviel and articles on MedTech and pharma trends for 2025, the eligibility of life sciences companies for qualified small...more

1/9/2025 / Brand , Initial Public Offering (IPO) , Intellectual Property Protection , Life Sciences , Medical Devices , Patents , Pharmaceutical Industry , Regulatory Reform , Venture Capital

FDA Issues Multiple Guidances Supporting Clinical Trial Innovation

In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow...more

9/27/2024 / Biotechnology , Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Research , Pharmaceutical Industry

FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices

The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more

9/4/2024 / Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

FDA Publishes Machine Learning Transparency Guiding Principles for Medical Devices

Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more

7/10/2024 / Artificial Intelligence , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Medical Software , Transparency

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

7/3/2024 / Clinical Laboratories , Compliance , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Manufacturers , Medical Devices

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