FDA
The article highlights the key points related to the regulatory requirements for dental curing lights intended to be marketed and used in the US.
FDA
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.
FDA
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.
FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
CBRN
The article provides a brief overview of a special regulatory framework introduced for certain in vitro diagnostic medical devices.
