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Medical Devices › Warranties

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

Morgan Lewis - Tech & Sourcing

Are There Hidden Defects in Medical Device Warranties? A Conversation with Dennis Gucciardo

Morgan Lewis - Tech & Sourcing on

As part of our Spotlight series, Dennis C. Gucciardo, who counsels medical device manufacturers throughout the product lifecycle in the US Food and Drug Administration (FDA) regulatory context, shares insight into some...more

Morgan Lewis

OIG Embraces Broader Anti-Kickback Statute Safe Harbor Protection for Warranties

Morgan Lewis on

The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects...more

Baker Donelson

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

Baker Donelson on

In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

Mintz - Health Care Viewpoints

OIG Opinion Illustrates the Need for New AKS Safe Harbors

Mintz - Health Care Viewpoints on

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

Hogan Lovells

OIG gives the green light to another innovative warranty

Hogan Lovells on

Last week, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 18-10, advising that the OIG would not pursue an enforcement action under the Anti-Kickback Statute (AKS)...more

Polsinelli

OIG Approves Warranty Program for Bundled Products Used in Joint Replacement Surgery

Polsinelli on

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently released Advisory Opinion 18-10, which approved a proposed arrangement involving a manufacturer of medical devices and wound care...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

Robinson+Cole Health Law Diagnosis on

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Fall 2017

Wilson Sonsini Goodrich & Rosati on

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Benesch

Benesch’s 2nd Annual 3D Printing Seminar (A Summary Repeat)

Benesch on

Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more

Foley Hoag LLP

Product Liability Update -- October 1, 2013

Foley Hoag LLP on

In This Issue: ..Massachusetts Supreme Judicial Court (Finally) Enforces Agreement for Individualized Arbitration of Unfair and Deceptive Practices Claims Following United States Supreme Court Decision Reversing...more

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