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Life Sciences › OEM › Food and Drug Administration (FDA)

Arnall Golden Gregory LLP

Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device Reprocessor for Changes to Marketed Products

Arnall Golden Gregory LLP on

“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor...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Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more

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