FDA

The Waiting Game

It’s been a weird week.  The “Frankenstorm” also known as Sandy blew through Washington, closing everything from the stalwart federal government to the Metro system.  OFW Law weathered the storm pretty well, though the view outside my window of the muddy, debris-filled Potomac is an ever-present reminder that our problems pale in comparison to those …

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Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance

By Kathryn E. Balmford Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical devices to FDA’s.  When asked by a reporter whether proposed changes to FDA’s 510(k) premarket clearance system …

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Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

The number of class action lawsuits targeting food labeling claims has risen dramatically over the past few years.  These are cases alleging that a food product’s labeling (and/or advertising) violates state consumer protection laws.  As a result, when a food company now considers whether to include an aggressive claim in commercial marketing, it should consider …

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The FDA Regulatory Challenges of Software Interoperability and Part 806

By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the industry have understood and used software validation principles ever since the enactment of the Medical Device …

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What’s Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not …

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