On September 25, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance that sets out the agency’s recommendations on nonclinical testing, clinical data, and labeling for premarket submissions involving certain robotically assisted surgical devices (RASDs). The FDA is
Wilson Sonsini Goodrich & Rosati
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Information Sharing Between the SEC and the FDA on Regulated Products
By Eva Yin, Ty Kayam & Nawa Lodin
On August 31, 2026, the Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a memorandum of understanding (MOU) governing the sharing of nonpublic information relating to FDA-regulated products and activities. The MOU is not…
What the FTC’s Health App Policy Withdrawal Actually Changes
By Jodi Daniel, Ty Kayam & Brandon Ge
The Federal Trade Commission (FTC) has rescinded its 2021 Statement of the Commission on Breaches by Health Apps and Other Connected Devices. In its September 9, 2026, rescission, the Commission offered several reasons for the withdrawal and described each as…
Senators Warren, Wyden, and Merkley Introduce Federal CPOM Law
On September 16, 2026, Senators Elizabeth Warren (D-MA), Ron Wyden (D-OR), and Jeff Merkley (D-OR)—along with House companion sponsors Representatives Val Hoyle (D-OR), Suhas Subramanyam (D-VA), and Alexandria Ocasio-Cortez (D-NY)—introduced the Stop Corporate Takeovers of Physicians Act of 2026.…
Evolving Expectations for AI in Mental Health
Artificial intelligence (AI)-enabled mental health products, including chatbots, digital companions, and coaching tools, are attracting increased attention from regulators, policymakers, and courts. Building on Wilson Sonsini’s previous alert, Legal Framework for AI in Mental Healthcare, this advisory discusses recent…
European Commission Proposes “EU KIDS Act” to Restrict Children’s Access to Online Services
On September 17, 2026, the European Commission (EC) published a proposed “EU KIDS Act,” which would impose minimum-age requirements to access social media and video-sharing platforms, subject to mandatory age verification, as well as an obligation for covered…
Corp Fin Adds Three CFIs on Shareholder Engagement and Schedule 13G Eligibility
On September 2, 2026, the staff of the Division of Corporation Finance published three new Corporation Finance Interpretations (CFIs) clarifying when a shareholder’s engagement with an issuer will not disqualify the shareholder from reporting beneficial ownership on the short-form Schedule…
FDA Introduces a Potential Review Architecture for Generative AI-Enabled Medical Devices
By Jodi Daniel & Ty Kayam
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health recently published a discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, offering one of the FDA’s most…
SEC Announces 37% Decrease in Registration Fee Rates Effective October 1, 2026
On August 21, 2026, the U.S. Securities and Exchange Commission (SEC) announced a decrease in the fees that public companies and other issuers will be required to pay to register their securities, from $138.10 per million dollars to $87.00 per…
CalPrivacy Authorizes Rulemaking on Opt-Out Signals, Raises Data Broker Fees, and Starts the Clock on DROP Amendment Comment Period
At its August 6–7, 2026, board meetings, the California Privacy Protection Agency (CalPrivacy) Board directed staff to prepare formal rulemaking to name Global Privacy Control (GPC) in the California Consumer Privacy Act (CCPA) regulations and tighten how opt-out preference signals…