Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Attorneys Jolene Fernandes, James Ewing, Lisamarie Collins, Jacki Lin and Linda Wu contributed an article to Bloomberg BNA’s Medical Devices Law & Industry Report, “Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?,” on October 28, 2015. The article laboratory developed test (LDT) providers and new U.S. Food and Drug Administration (FDA) oversight that requires LDTs providers to consider if their LDTs constitute moderate-risk or high-risk devices subject to FDA oversight. The article reviews emerging areas of regulation for LDT providers; 510(k) statements and real world consequences to patent assets; and practical solutions for mitigating risk.