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 further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.
Health Canada, the Canadian medical regulating authority, announced that new requirements, which was under development since 2018, came into effect this week. The scope of new requirements covers issues related to cybersecurity threats. In accordance with applicable...
FDA
