Eva Yin on Food and Drug Administration (FDA)

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more

8/22/2025 / Biometric Information , Digital Health , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Medical Devices , Mobile Health Apps , Popular , Regulatory Oversight , Regulatory Requirements , Wellness Programs

FDA Announces “Priorities for a New FDA” and a New Vouchers Program to Address National Priorities

On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...more

6/25/2025 / Artificial Intelligence , Biosimilars , Drug Pricing , Food and Drug Administration (FDA) , Healthcare Reform , New Regulations , Popular , Prescription Drugs , Public Health , Regulatory Reform , Regulatory Requirements

[Event] 32nd Annual Medical Device & Digital Health Conference - June 5th - 6th, San Francisco, CA

Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more

5/8/2025 / Acquisitions , Antitrust Violations , Artificial Intelligence , CEOs , Digital Health , Emerging Growth Companies , Equity Compensation , Events , Executive Compensation , Exit Strategies , Food and Drug Administration (FDA) , Innovation , Investors , Med Tech , Medical Devices , Mergers , Patents , Startups , Venture Capital

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

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

3/13/2025 / Drug Compounding , Enforcement Actions , Food and Drug Administration (FDA) , Pharmaceutical Industry , Popular , Preliminary Injunctions , Prescription Drugs , Regulatory Oversight , Regulatory Requirements

FDA Announced Removal of Tirzepatide from the Drug Shortage List

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more

1/3/2025 / Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Popular , Prescription Drugs , Supply Chain , Supply Shortages

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

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

8/1/2024 / Data-Sharing , Drug Testing , Electronic Medical Records , Food and Drug Administration (FDA) , Health Care Providers , Medical Research , Pharmaceutical Industry , Prescription Drugs

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

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

FTC Disputes Patent Listings of 10 Brand Drug Makers as Improperly Listed in FDA’s Orange Book

On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more

11/16/2023 / Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , FTC Act , Hatch-Waxman , Orange Book , Patent Infringement , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Unfair Competition

FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to regulate laboratory-developed tests (LDTs). The rule, if finalized, would amend FDA regulations to broaden the definition of “in...more

10/6/2023 / Clinical Laboratories , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Proposed Rules

California Prepares First-of-Its-Kind Food Additive Ban in the United States

Last week, the California legislature approved Assembly Bill 418, the California Food Safety Act (AB 418), which is headed to Governor Gavin Newsom to sign or veto by October 14, 2023....more

9/19/2023 / Additive Manufacturing , California , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , New Legislation , Public Health

FDA Cracks Down on Unapproved Eye Products

On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more

9/19/2023 / Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Labeling , Manufacturers , Medical Devices , Personal Care Products , Pharmaceutical Industry , Product Labels

HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

9/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Federal Circuit Affirms Jazz Pharmaceutical's Risk Evaluation and Mitigation Strategy Patent Is Not Listable in Orange Book

On February 24, 2023, the Federal Circuit held that Jazz Pharmaceuticals, Inc. (Jazz) must delist U.S. Patent No. 8,731,963 (the ’963 Patent) from the U.S. Food and Drug Administration’s (FDA’s) “Orange Book” because the...more

3/14/2023 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Patent Litigation , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

Eva Yin

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