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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FDA Releases Draft Guidance on its Voluntary Qualified Importer Program

Client Alert
Kathleen M. Murphy, Mollie D. Sitkowski

On June 5, 2015, the Food and Drug Administration (FDA) announced the publication of its Draft Guidance on its Voluntary Qualified Importer Program (VQIP).

The DOL Announces Proposed Revisions to FLSA Regulations Doubling the Minimum Salary Requirement for Exempt Employees

Client Alert
Dennis M. Mulgrew, Jr.

More than 15 months after President Obama issued a Presidential Memorandum directing the Secretary of Labor “to propose revisions to modernize and streamline the existing [FLSA] overtime regulations,” the Department of Labor on June 30, 2015 finally issued a Notice of Proposed Rulemaking (NPRM) detailing its proposed revisions.

The Validus Decision: Potential Impact on FET Refund Claims

Client Alert
Thomas Gray, John W. Weber, Jr.

By Thomas Gray and John W. Weber, Jr. Summary and Highlights: On May 26th, the U.S. Court of Appeals for the District of Columbia Circuit held in favor of Validus Holdings Ltd. (“Validus Re”), a Bermuda reinsurance company, in the federal government’s appeal of the decision in Validus Reinsurance Ltd. v. United States, 113 AFTR 2d 2014-813 (D.D.C. 2014).[1] The case deals with the imposition of the federal insurance premiums excise tax (FET) imposed under Secti...

CBP Offers to Negotiate With Foreign Customs on Exporters' Behalf

Client Alert
Kathleen M. Murphy, Mollie D. Sitkowski

On June 18, 2015, U.S. Customs and Border Protection (CBP) announced in the Federal Register that it would be accepting “requests for assistance” from exporters who are dealing with valuation or classification issues with foreign customs agencies.

Third Circuit Addresses Structured Dismissal of Bankruptcy Case

The Legal Intelligencer
Joseph N. Argentina, Jr., Andrew C. Kassner

Philadelphia and Wilmington partner Andy Kassner and associate Joe Argentina published an article in The Legal Intelligencer titled, “Third Circuit Addresses Structured Dismissal of Bankruptcy Case.”