FDA
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
FDA
The article highlights the aspects related to physical laboratory testing to be conducted by the parties responsible for magnetic resonance products to ensure they are safe and efficient when used for the initial intended purpose.
FDA
The article highlights the key points associated with the electronic submissions template described by the US authority.
FDA
The article highlights the aspects related to clinical images to be submitted by the applicant and also describes the approach to be applied concerning modifications to medical devices covered by the scope of the guidance.
FDA
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
