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.

To read the entire article, click here.

03/06/2015

Telecommunications in Cuba and the U.S. Embargo

Drinker Biddle Client Alert
Eduardo R. Guzman

03/04/2015

First Ladies Facing Ethics Complaints

The Legal Intelligencer
Scott A. Coffina

03/04/2015

Punishing Good Deeds in California

Unclaimed Property Alert
Jason P. Gosselin, Kaitlin McKenzie-Fiumara, Geoffrey A. Sawyer III

03/02/2015

SEC Provides Guidance on Receipt of Gifts by Fund Advisory Personnel

Investment Management Alert

03/02/2015

Goodyear Settles SEC’s FCPA Charges for $16M – Investigation Underscores Importance of Pre-Acquisition Due Diligence and Oversight of Foreign Subsidiaries

FCPA Bulletin
Emily T. Broach, Charles S. Leeper