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Manufacturers 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?

Stinson LLP on

Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more

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