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 Viability of the Equitable Mootness Doctrine in the Third Circuit: A Moot Point?

Client Alert
Marita S. Erbeck

By Marita S. Erbeck and Jennifer M. Roussil In the bankruptcy context, effectively appealing an order confirming a debtor’s plan of reorganization is not always a sure bet, as a court may refuse to entertain the appeal in the name of equitable mootness.  Equitable mootness – “a judge-made abstention doctrine that allows a court to avoid hearing the merits of a bankruptcy appeal because implementing the requested relief would cause havoc”[1] – empowers a ...

What Does the Supreme Court's Same-Sex Marriage Ruling Mean for Employee Benefit Plans?

Client Alert
Summer Conley, Robert L. Jensen, Sarah Bassler Millar

On June 26, 2015, the U.S. Supreme Court ruled in Obergefell v. Hodges that states must license and recognize a marriage between two people of the same sex.

WTO Members Agree to Cut Tariffs on IT Products

Client Alert
Kathleen M. Murphy, Mollie D. Sitkowski

On Friday, July 24, 2015, the World Trade Organization (WTO) announced that more than 50 of its member countries had agreed to cut tariffs on hundreds of information technology (IT) products.

Something Old, Something New: Accounting for Accountable Care in Antitrust Analysis

Health Law Handbook
Robert W. McCann

In this chapter, Rob illustrates the tension between antitrust enforcement and clinical collaboration models under the Affordable Care Act, discusses the St. Luke’s decision, and explores the intersection between health care delivery reform and antitrust law.

Senate Passes Another Criminal Antitrust Anti-Retaliation Act July 30, 2015

Client Alert
Todd N. Hutchison, Paul H. Saint-Antoine, Ronald A. Sarachan, James J. Williamson II

The Senate recently passed with unanimous consent the Criminal Antitrust Anti-Retaliation Act of 2015 (“CAARA”) after minor tweaks to two definitions. CAARA provides anti-retaliation protection to whistleblowers who give information to their employer or the federal government concerning criminal violations of antitrust laws.