
FDA Guidance on Considerations for Weight Loss Devices: Benefit-Risk Assessment
The article provides a general overview of the existing regulatory framework associated with adverse events.
The article provides a general overview of the existing regulatory framework associated with adverse events.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to deciding when to submit a 510(k) for a software change to an existing...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a final guidance document dedicated to the submission of 510(k) notifications for changes to medical devices that have already been...
This article has been updated May 29, 2025. The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The medical device industry is one of the most heavily regulated sectors in the United States, with...
Any manufacturer who wants to legally market their medical device in the US intended for human use has to get FDA approval. Any class I, II, or III devices, which is not exempt and does not require premarket approval must fulfill the requirements of a 510(k) of the...