Sunday, January 30, 2011

US FDA CDRH 2011 Strategic Priorities

Recently FDA published its 2011 Strategic Poriorities document for CDRH.  A PDF version of the document is at

Among the identified goas was one set for January 31, 2011 (tomorrow).  FDA indicated its goal was:

  • By January 31, 2011, finalize a framework for validation and review of array CGH applications.

  • A Public Meeting was held on June 30, 2010 and a public docket was established which can be viewed at!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259

    It will be interesting to see if tomorrow brings the announcement of the promised framework for validation and review of these tests.  I'm sure it will be virewed with great interest by the medical device industry as well as the the laboratory and academic communities.  It will surely give our first glimpse  into the direction FDA will take concerning the regulatory of laboratory developed tests (LDTs).  Will FDA meeting its stated goal?

    No comments:

    Post a Comment