Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)
Posts published in March 2019
Reorganization of The Center for Devices and Radiological Health
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials…
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry
FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051
Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited
Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems Consultation: Proposed new…
Brexit – Implications for therapeutic goods in Australia
Team-NB-Press-Release-Survey-Capacities-February-20190228
In accordance with Articles 23 IVDR and 26 MDR, having due regard to the views provided by the MDCG, the CND nomenclature, to be mapped to…