Hello Just to clear a few points. 1. Stethoscopes are not regulated with the FDA but US Customs require the exporting company to be registered with the FDA. 2. Partly because of the switching of diaphragms, 3M Littmann has sued Kila Labs in US District Court, Minnesota. A jury trail will be held in the summer of 2010 3. The consensus seems to be that tunable diaphragms are out. Fixed ones seem to be just as good. Prad Kila Labs