FDA Q&A Document on Addressing Misinformation About Devices and Drugs: General Communication
The new article explains the matters related to general medical product communication in the context of addressing misinformation about the products.
The new article explains the matters related to general medical product communication in the context of addressing misinformation about the products.
The article outlines the key points to be included in the application for authorization to conduct clinical trials in Denmark.
The article highlights the key points related to the regulatory requirements for dental curing lights intended to be marketed and used in the US.
The new article pays special attention to the matters related to electromagnetic compatibility, as well as non-clinical performance testing the products covered by the scope of the guidance should undergo in order to demonstrate compliance with the relevant regulatory requirements in terms of safety and effectiveness.
The new article provides additional details regarding the specific aspects associated with dental curing lights and the regulatory requirements they are subject to under the existing legal framework.