Section 510

News & Analysis as of

Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more

Sixth Circuit: ERISA’s Whistleblower Provision Doesn’t Protect Giving Information

The Sixth Circuit (in a 2-1 decision) recently held that ERISA Section 510 does not protect unsolicited employee complaints. See Sexton v. Panel Processing, Inc., 2014 U.S. App. LEXIS 8752 (6th Cir. May 9, 2014). Plaintiff...more

Employment Relationship Not Required For Claim Of ERISA Violation For Benefit Rights

In a recent Seventh Circuit Court of Appeals decision successfully litigated by Laner Muchin, the Court addressed novel aspects of whether an employer interfered with employees’ benefit rights in violation of ERISA. The case...more

Seventh Circuit Resolves Question of Whether Informal Complaints Can Provide the Foundation for Retaliation under ERISA

Section 510 of the Employee Retirement Income Security Act (ERISA) prohibits retaliation “against any person because he has given information or has testified or is about to testify in any inquiry or proceeding related to...more

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