Third Wave’s Cystic Fibrosis DNA Test Gains FDA Approval.  Third Wave Technologies, Inc., recently gained FDA approval for its cystic-fibrosis DNA test.  The test is designed to be administered to adults, children, and newborn infants to determine whether they carry the genes for cystic fibrosis.  In studies submitted to FDA, the device was able to identify 100% of the samples tested that carried cystic fibrosis.  Additional information is available at www.devicelink.com. 

Device Industry Experts Warn of FCPA Investigations.  According to legal experts in the medical device arena, device firms can expect to be increasingly scrutinized for violations of the Foreign Corrupt Practices Act (“FCPA”) in the near future.  Although in the past, such investigations have focused primarily on pharmaceutical companies, device firms have recently found themselves the subject of so called “sweep cases,” by which the Securities and Exchange Commission (“SEC”) tests the overall compliance of the industry.  As the U.S. medical device industry becomes increasingly global, device firms should expect that FCPA investigations will continue to increase.  Additional information is available at www.fdanews.com.  

PMA Preemption Unclear for Combination Products.  Plaintiff’s lawyers are arguing that drug-device combination products should not be entitled to federal preemption under the Federal Food Drug and Cosmetic Act (“FDC Act”), because the FDC Act does not contain a similar provision that grants federal preemption to pharmaceuticals.  Thus, some claim that such combination products are not covered by the Supreme Court’s February 20, 2008, decision in Riegel v. Medtronic, which held that devices that are approved through FDA’s rigorous PMA approval process are entitled to federal preemption against products liability claims.  Additional information is available at www.thegraysheet.com (paid subscription service).