News & Analysis as of

Warranties Advisory Opinions Medical Devices

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

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

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

Robinson+Cole Health Law Diagnosis

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

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

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