Proposed Rule on UDI Database Expected Soon, CDRH Says

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. Class I and II devices would have to be in compliance within five years of the rule’s passage.

CDRH ran a pilot version of the UDI program last year. While devicemakers were receptive to the prototype, they were concerned that it required information that may be proprietary, unnecessary or not always readily available.
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