Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?
28 October 2015
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.
Author(s)
Related Insights
25 April 2024
On Trial
A Trial Lawyer’s Trial Lawyer: Paul Callan On Trial
In this episode of On Trial, host Christopher DeGennaro sits down with seasoned trial lawyer and CNN legal commentator Paul Callan, former deputy chief of the Brooklyn District Attorney’s Office, with 30 years’ experience as a trial lawyer.
25 April 2024
Health Care Law Today
New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers
The Office of Inspector General recently issued a new favorable advisory opinion regarding patient assistance programs for 12 specific disease funds.
09 May 2024
Events
The FTC Noncompete Rule: Where Do We Go From Here?
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) voted to finalize a rule abolishing the vast majority of employee noncompetes across the United States.