FDA
The Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA), has published detailed information about the Patient Science and Engagement Program – the new approach intended to improve the engagement of patients in...
Canada
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, issued a compliance program describing the inspections related to CDER-led or CDRH-led combination products. The document provides the requirements for different...
FDA
The Center for Devices and Radiological Health (CDRH), the unit of the Food and Drug Administration (FDA) responsible for medical devices regulation, issued guidance describing how medical device manufacturers should notify CDRH of a permanent discontinuance or...
North America
The Center for Devices and Radiological Health (CDRH), the FDA division focused on ensuring the safety of medical devices available on the market, published new online learning tools intended to assist medical device manufacturers in familiarizing themselves with...
North America
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on manufacturing and performance of medical devices,...
