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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft guidance providing additional details regarding eSubmissions.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 medical devices, has published a guidance document dedicated to the specific criteria applied by the Agency when determining whether a 510(k) Premarket Notification...
COVID-19 The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices, issued guidance dedicated to formal meetings and user fee applications for medical devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19)...
FDA The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions in the context of the outbreak of the...
North America The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to premarket notification 510(k) submissions for bone anchor devices. Bone Anchor: General Approaches The new guidance issued by the US regulating...
