{{ phone }} {{ location }}

Emergo by UL logo

         

CDRH

US FDA为医疗器械合规性评估认证计划试点项目添加详细信息

Emergo关键点摘要:

  • US FDA针对其即将推出的合格评定认证计划(ASCA, Accreditation Scheme for Conformity Assessment)试点项目提供了更多信息。
  • ASCA将包括至少五个FDA认可的医疗器械自愿共识标准。
  • 试点项目预计将于2020年9月之前推出。

Obama’s 2012 Budget Includes 4.8% Increase for CDRH

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) would see an appropriation of $329 million—a 4.8% increase over current levels—in the Obama administration’s proposed 2012 budget. Total CDRH funding would total $395 million, with $66 million from industry user fees, if the administration has its druthers, according to The Gray Sheet .

CDRH Rolls Out 2011 Priorities

On the heels of revealing some of its 510(k) reform plans on January 19, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) medical device regulatory unit has published a list of its four strategic priorities for 2011--including taking a more assertive role in promoting development of products the unit deems necessary to combat public health challenges.