FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and requests associated thereto. The document provides an overview...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and regulatory framework associated thereto. Table of Contents Due...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document on infusion pumps. Table of Contents The document addresses the most important...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft guidance providing additional details regarding eSubmissions. The document is intended to assist medical device manufacturers...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for reprocessing medical devices in healthcare settings. It is important...
