FDA Announces Its Plan For Changes to the 510(k) "Approval" Pathway

Posted on January 27, 2011 by Sheppard Mullin

By Peter S. Reichertz and Allie Frumin

January 19, FDA announced its plan to modify the 510(k) “approval” pathway, the most common review path for medical devices. Specifically, FDA released a report containing twenty-five actions it intends to take in 2011 to “improve” the review process. Importantly, however, no changes have yet been made to the process; FDA has just announced its plan of action of how it intends to address potential changes to the process.
 

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E-CIGARETTES GET A "SMOKING" BREAK: D.C. Circuit Clarifies Scope of FDA's Authority Over E-Cigarettes

Posted on January 4, 2011 by Sheppard Mullin

By Deborah M. Shelton and Allie Frumin

On Tuesday December 7th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred to as “e-cigarettes”) at issue in that case. Instead, the court affirmed the district court’s finding that FDA’s authority over these e-cigarettes, as labeled, was limited to that over traditional tobacco products.
 

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