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.

11/20/2014

Indemnification and Reimbursement Sought from Insurers Based on Allegedly Fraudulent Funding Program: Fifth Third Bancorp v. Ace Insurance Company

Secondary Market Alert
Stephen C. Baker, Robert J. Mancuso, Nolan B. Tully, Katherine Villanueva

11/19/2014

Why the Supreme Court Decided to Hear King v. Burwell

Law360
Jesse A. Witten

11/17/2014

Player Eligibility Above Academic Integrity? Ways to Avoid UNC-Chapel Hill’s Academic Scandal

Client Alert
Scott A. Coffina, Ginene A. Lewis

11/12/2014

2014 Midterm Election Outcome Analysis and Outlook for 114th Congress

Health Care Insight

11/11/2014

Pennsylvania Department of Revenue Clarifies Changes to New Realty Transfer Tax Law

Client Alert
Stephen D. D. Hamilton, Kaitlin McKenzie-Fiumara, David Shechtman