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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The Tide Continues to Turn: Texas Appellate Court Confirms High Burden for SSPA “Best Interest” Standard

Life Insurance & Annuities Alert
Christian Brito , Michael J. Miller, Lisa D. Stern

Since the enactment of Section 5891 of the Internal Revenue Code and the various structured settlement protection acts (“SSPAs”), the volume of structured settlement factoring transactions has soared.

The NLRB Expands the Definition of “Joint Employer”


William R. Horwitz, Philippe A. Lebel

Yesterday, the National Labor Relations Board (the “NLRB” or “Board”) issued a decision greatly expanding the standard for determining whether a company may be deemed a “joint employer.”

Third Circuit Again Reviews Equitable Mootness Doctrine for Bankruptcy Appeals

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

Andy and Joe discuss the implementation of the equitable mootness doctrine in chapter 11 reorganization appeals.

Post Limelight, Could Patent Act Be More User-Friendly?

Law360
Robert L. Stoll

Bob’s article discussed the new standards for direct infringement set forth by the United States Court of Appeals for the Federal Circuit.

Federal Court Rejects Invalid Theory of FCPA “Accomplice” Liability

FCPA Bulletin
Charles S. Leeper, Joshua M. Link

The United States District Court for the District of Connecticut recently held that a non-resident foreign national cannot be subject to criminal liability under the (FCPA) when the defendant is not an agent of a domestic concern and did not commit the alleged acts while physically present in the United States.