Regulatory Open Forum

On June 13, 2013, the FDA's Microbiology Advisory panel will discuss and make recommendations regarding the possible reclassification of influenza detection devices, currently regulated as class I. The committee's specific discussion will involve making recommendations regarding regulatory classification to either confirm class I or reclassify these devices into class II with special controls. As the industry represenentative, I am open to comments to best represent the industry position. If you have comments, please send them to me directly at GlenF92067@aol.com before June 10th.  The FDA announcement/details may be found at:  http://www.fda.gov/AdvisoryCommittees/Calendar/ucm351035.htm

-------------------------------------------
Glen Freiberg RAC
President
Rancho Santa Fe CA
United States
-------------------------------------------