RAPS

How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out

US regulators plan to launch a new study of medical device labeling in the hopes of determining if a standardized format could help healthcare providers to better understand the risks and benefits of ...
RAPS

Interoperable Medical Devices: FDA Offers Design, Labeling Considerations

With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on ...
Milwaukee Journal Sentinel

Language Scientific Outlines What “Quality” Means in Medical Device Labeling Translation

In the highly regulated field of medical device labeling translation, ensuring that every translated word meets both linguistic and regulatory requirements is critical. A company specializing in ...
JD Supra

Marketing Medical Devices: Navigating Increased FDA Scrutiny

With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing ...