Dec 9 - 6:12
The Food and Drug Administration (FDA), the medical device regulating authority of the United States, announced public consultations regarding the requirements of the pediatric medical device pre-marketing application...
Dec 6 - 5:17
Health Canada, the Canadian national regulating authority responsible for the regulation of the healthcare sector, announced the creation of the Medical Device Directorate (MDD). According to the announcement, the...
Dec 2 - 5:58
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...
Nov 25 - 6:55
The US medical device circulation regulating authority, the Food and Drugs Administration (FDA), has issued guidance describing the issues related to denial in handling an export certificate. The Scope of the Guidance:...
Nov 8 - 2:00
The Food and Drug Administration (FDA) has published a document amending the list of consensus standards utilized in the review of premarket submissions. Voluntary Consensus Standards Recognized by FDA The 1997 Food...
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...
