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Third-Party Service Provider Medical Devices

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Stinson LLP

Medical Device Third-Party Servicers: Will FDA Treat You as a Manufacturer?

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Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 4, 2019

Welcome - Welcome to the fourth 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal...more

Robins Kaplan LLP

The Tech Industry’s Next Frontier?

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Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

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