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 Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....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...
COVID-19
The Food and Drug Administration (FDA) has issued a special warning describing the risk for patients associated with the protective barrier enclosures without negative pressure used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the cutaneous electrodes for recording purposes. In particular, the document constitutes a final version of the guidance, while the initial draft was published by the FDA in...
