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Regulatory Focus™ > News Articles > CDRH Releases Project Statuses for 26 Device Classes

CDRH Releases Project Statuses for 26 Device Classes

Posted 21 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an updated schedule describing the classification timelines of 26 device classes.

The 17 February release of the schedule is a part of CDRH's 515 Program Initiative, which is part of CDRH's overall Transparency Initiative. The 515 Program is named after Section 515 of the Federal Food, Drug and Cosmetic Act (FD&C Act) which covers the reclassification of medical devices, and seeks to provide transparency in the development of new medical device risk classifications.

As of 2009, 26 medical devices were awaiting final classification. There are currently 22 device classes in various stages of classification development.  FDA has collected existing information on all 22 device classes, leaving 15 device classes at a benefit:risk assessment stage, one device class at a proposed rule stage and six device classes at in a post-proposed rule stage awaiting comment.


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