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.

12/19/2014

Affordable Care Act Considerations in Mergers and Acquisitions

Client Alert
Robert L. Jensen

12/18/2014

San Francisco’s Retail Workers Bill of Rights Has Passed: Are you ready?

Client Alert
Pascal Benyamini, Mark E. Terman

12/18/2014

DOL 2014 Fall Regulatory Agenda

Client Alert
Bruce L. Ashton, Bradford P. Campbell, Joan M. Neri, Fred Reish, Joshua J. Waldbeser

12/18/2014

9 Health Care Legal Issues to Follow in 2015

Health Care Insight
Robert W. McCann, Douglas B. Swill

12/17/2014

One Step Closer to Normalizing Relations with Cuba

Client Alert
Joan Koenig, Mollie D. Sitkowski