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.
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.
FDA
