Thursday, February 10, 2011

Public Docket for comments on Array-Based Cytogenetic Tests

Thought it wold be interesting to see the public comments submitted tot he docket for this item.  See previous posts where FDA (CDRH) had projected issuing a framework for the validation and review of array CGH assays.

Here is a link to the docket at!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259 - Your Voice in Federal Decision Making
There have really only been 2 comments posted from the public.

The College of American Pathologists (!documentDetail;D=FDA-2010-N-0259-0003.1) and
The Cleveland Clinic (!documentDetail;D=FDA-2010-N-0259-0002.1)

The only other items posted are the original Federal Register notice announcing the June 30, 2010 public meeting (!documentDetail;D=FDA-2010-N-0259-0001) and the actual transcript of the public meeting (!documentDetail;D=FDA-2010-N-0259-0004).

Interestingly, FDA does not even seem to have posted the various presentations given at the public meeting to the docket.

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