Sep 25 - 2:21
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The...
Sep 20 - 6:32
The FDA has finalized a guidance about citizen petitions against the approval of drugs, which delays the application process, and what they look for in petition submissions as well as why submissions might be denied....
Sep 16 - 5:43
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released four final guidances in an effort to improve the efficiency of its 510(k) marketing authorization pathway. Special...
Sep 13 - 4:10
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult...
Sep 12 - 6:04
The Food and Drugs Administration (FDA), the US authorized body who provides regulation and supervision in the sphere of medical products and devices, finalized a guidance on De Novo applications. De Novo Pathway De...
Sep 10 - 5:26
The US Food and Drug Administration (FDA) finalized guidance on the Humanitarian Device Exemption (HDE) program on Thursday, reflecting amendments made by the 21st Century Cures Act (Cures Act) and the FDA...
