Publication - 11/22/2013

FDA Final Guidance on Mobile Medical Applications

Life Sciences Now

On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs). The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.

The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement discretion because these applications pose a low risk to the public; and (3) mobile apps that meet the definition of a medical device and which the FDA will regulate due to the significant potential risk to patient safety.

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U.S. Department of Education Issues New Guidance on Incentive Compensation Regulations

Client Alert
John R. Przypyszny, Jonathan D. Tarnow

On Friday, November 27, 2015, the U.S. Department of Education (the “Department”) will issue guidance in the Federal Register regarding its October 29, 2010 changes to the incentive compensation regulations at 34 C.F.R. § 668.14(b)(22) that took legal effect July 1, 2011.

Casino Not Liable to Return Proceeds of Fraudulent Transfers

The Legal Intelligencer
Joseph N. Argentina, Jr., Andrew C. Kassner

Andy Kassner and Joe Argentina published an article discussing the recent Seventh Circuit Court of Appeals review of whether a bankruptcy trustee can recover funds from a casino where the debtor gambled with funds obtained by fraudulent transfers from a debtor.

U.S. International Trade Commission Makes Final Injury Determination On Supercalendered Paper From Canada

Client Alert
Richard P. Ferrin, Douglas J. Heffner

On November 18, 2015, the U.S. International Trade Commission (ITC) voted affirmative in connection with its final injury investigation on supercalendered paper from Canada.

“Socially Responsible” Investing Under ERISA: New DOL Guidance

Client Alert
Bruce L. Ashton, Fred Reish, Joshua J. Waldbeser

In this Alert, we outline a fiduciary process that committees should follow in evaluating ETIs versus other investment alternatives, based on the key points in the Bulletin.

Cyberspace Law: Recent Trends in the United States and the European Union

Understanding Developments in Cyberspace Law: Leading Lawyers on Analyzing Recent Trends, Case Laws, and Legal Strategies Affecting the Internet Landscape
Kenneth K. Dort

Ken’s chapter is titled, “Cyberspace Law: Recent Trends in the United States and the European Union.”