FDA
The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published guidance on micro-needling products. Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....
FDA
The Saudi Food and Drug Administration (SFDA) issued updated guidance requirements for medical device listing and marketing authorization. The document is intended to provide medical device manufacturers, their authorized representatives, distributors, and other...
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
North America
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general surgery. The scope of the document covers devices based...
North America
This article was updated June 2, 2025. The FDA finalized guidance in 2019 regarding placebos and blinding. FDA’s Guidance on Placebos:A placebo is an inactive substance or procedure used in clinical trials to determine whether participant responses result from...
North America
This article has been updated May 29, 2025. The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The medical device industry is one of the most heavily regulated sectors in the United States, with...
