BfArM
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
FDA
The article provides an overview of the existing framework for electronic thermometers.
HSA
The new article highlights the aspects related to the general principles of clinical evaluation.
FDA
The new article describes in detail the enforcement policy introduced by the authority and also highlights the key points to be considered in order to comply with it.
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.
