Tuesday, February 1, 2011

Where is the Framework for Validation and Review of Array CGH Applications?

In its "2011 Strategic Priorities" document for CDRH, FDA projected that by yesterday (January 31, 2011), it would finalize a framework for the validation and review of array CGH applications.  Yesterday came and went without any news about the status of the framework.  If I was an array manufacturer (or user) I'd be most curious to know what was happening.  (Interesting that it was to be finalized before even issued as a draft).

Is it an oops - "We didn't realize it was due" or maybe "the dog ate it" or maybe
"We bit off more than we could chew - it's "coming soon".

So far FDA is 1 due date passed and 0 goals met.  24 more to go.

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