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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CIT Contains “Parts of” Provisions

Client Alert
Kathleen M. Murphy, Mollie D. Sitkowski

On January 21, 2016, the Court of International Trade (CIT) agreed with Customs and Border Protection (CBP) and held that Container Store storage units were properly classified as base metal mountings in heading 8302 of the Harmonized Tariff Schedule of the United States (HTSUS) rather than as parts of furniture in HTSUS heading 9403.

The Year in Social Enterprise: 2015 Legislative and Policy Review

Client Alert
Elizabeth K. Babson, Robert T. Esposito

The past year proved to be a landmark year in the brief history of the emerging social enterprise sector. Indeed, 2015 witnessed continued legislative efforts and important policy developments that illustrate the increased commitment to, and governmental support for, innovative social enterprise corporate forms and the impact investing thesis.

New Patent Subject-Matter Eligibility Test Hurts US Competitiveness

The Hill
Robert L. Stoll

The article discusses the deterioration of the United States’ position as the world leader in patent protection for new emerging technologies

The Big Chill: How The FCC’s Reading Of The TCPA Violates The First Amendment And Demands The Impossible

Law360
Bradley J. Andreozzi, Michael P. Daly, Justin O. Kay

Drinker Biddle’s TCPA team has been invited to contribute a regular column to Law360. In the first such column, partners Bradley Andreozzi, Michael Daly, and Justin Kay discuss how the FCC’s interpretations of the TCPA violate the First Amendment rights.

New Antidumping and Countervailing Duty Petitions on Truck and Bus Tires from China

Client Alert
Richard P. Ferrin, Douglas J. Heffner

On January 29, 2016, the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union filed antidumping (AD) and countervailing duty (CVD) petitions with the U.S. Department of Commerce (DOC) and U.S. International Trade Commission (ITC) regarding truck and bus tires from the People’s Republic of China.