The rule would mandate that agencies assess rules that affect small entities once every decade to ensure they were still appropriate.
Under a new proposed rule, the US Department of Health and Human Services would require its agencies to review all regulations every ten years to determine whether they are still necessary.
The rule, which was published in the Federal Register on 4 November, is known as Securing Updated and Necessary...
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
