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 article provides a general overview of the existing legal framework, paying attention to the most important regulatory matters.
FDA
The new article describes in detail certain specific aspects pertaining to the regulatory requirements dental composite resin devices should comply with in order to be allowed for marketing and use in the US.
FDA
The new article provides further clarification on the regulatory policy, emphasizing the key aspects to be considered in order to ensure compliance with the relevant regulatory requirements.
