The Centers for Medical & Medicaid Services (CMS), a part of the US Department of Health and Human Services (HHS), has published a policy on Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination...
The Association for the Advancement of Medical Instrumentation (AAMI) has published a Consensus Report intended to provide guidance regarding the safety-related aspects to be considered by the medical device manufacturers in the context of the Emergency Use...
The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module. Intended Purpose According to the official announcement published by...
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for overseas manufacturers, intended to provide foreign medical device manufacturers interested in placing their products on the market of the Kingdom of Saudi Arabia (KSA) with additional...
The US Food and Drug Administration (FDA) has issued a guidance dedicated to the benefit-risk factors to be considered in the context of product availability, compliance, and enforcement decisions with regard to the medical devices. Notes The document describes the...