United States
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...
United States
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...
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 Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....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 Food and Drug Administration (FDA) has published a guidance document providing standards specific information on biocompatibility testing of the medical device in the context of the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. Regulatory...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the self-monitoring blood glucose test systems intended for over-the-counter use. Important Notes The document represents a final version of the document issued previously in November 2018. The...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific...
