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CDRH

US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS:

  • US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity.
  • The guidance describes FDA’s process and criteria for determining complete or partial recognition or non-recognition of consensus standards.

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.