Supreme Court Justices Support FDA's Authority To Remedy Fraud Claims
This article was originally published in The Gray Sheet
Supreme Court Justice Stephen Breyer's comments supporting broad enforcement flexibility for FDA during oral arguments in The Buckman Co. v Plaintiffs' Legal Committee are consistent with his concurring opinion in the 1996 case Medtronic v. Lohr.
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The "intended use" statement in a 510(k) is "not a factual representation" of how a device will be used on the market, Kenneth Geller, attorney for the Buckman Co., contended before the U.S. Supreme Court Dec. 4.
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