FDA
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.
FDA
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
FDA
The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
FDA
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
