SZD CURRENTS: FDA’s 510(k) plan of action; Software protection debate; Online infringement jurisdiction standards


Under the microscope: FDA’s 510(k) Plan of Action

On Jan. 19, 2011, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) released its Plan of Action to improve the 510(k) clearance process for medical devices. The Plan outlines 25 steps CDRH intends to take in 2011 to foster medical device innovation, enhance regulatory predictability and improve patient safety.

The great software protection debate - to patent or copyright?

A common decision that many software developers face when creating new software programs is whether to pursue patent protection, copyright protection or both. Often, the answer lies in the nature of the software, including the function, novelty and obviousness in light of other inventions, and the needs and resources of the author or inventor.

Intellectual property considerations in contract terms and conditions

The terms and conditions in most contracts deal with the standard nuts-and-bolts aspects of production, schedules, delivery and payment, as well as general warranties and representations. Intellectual property issues concerning the ownership, control, sharing and enforcement of patents, trademarks, copyrights and trade secrets are rarely completely covered.

Web-specific jurisdiction standard adopted for online copyright infringement

The New York Court of Appeals held on March 24 in Penguin Group USA Inc. v. American Buddha that when determining long-arm jurisdiction, a different analysis applies to online copyright infringement than other forms of copyright infringement.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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