Thursday, June 5, 2014

FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress

FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress-thegraysheet: Two FDA draft guidance documents on professional and over-the-counter glucose meters were singled out for more criticism in a May 30 letter (PDF) from 85 House Democrats and Republicans to Commissioner Hamburg. “We are concerned that the draft guidances issued by FDA impose challenging requirements for accuracy that are inconsistent with internationally recognized standards,” members of the congressional Diabetes Caucus write, echoing complaints that have been lodged by meter makers, clinicians and lab managers.