CDRH expects to release a proposed rule for a unique device identifier (UDI) database this summer and is aiming at having a final rule in place by April 2011. Once the final rule is out, manufacturers of Class III devices will have one year to comply, Jay Crowley, CDRH’s senior adviser for patient safety, said at the Association for the Advancement of Medical Instrumentation/FDA International Conference on Medical Device Standards and Regulations last month. Class I and II devices would have to be in compliance within five years of the rule’s passage.

Source: http://fdanews.com

• на