Carmel, CA Lab Tests To Become Regulated By The FDA

The Food & Drug Administration (FDA) has announced that it will start regulating laboratory testing, something which has been vehemently fought against by laboratories and pathologists because they say it would stifle innovation on new tests.  As a compromise, the FDA has said it will phase in the rules over a nine year period and focus in the short term on tests where a wrong result would have the highest risk to the patient.  "Just as drugs need to be safe and effective for treating diseases, medical devices used to help diagnose disease and direct therapy also need to be safe and effective," FDA Commissioner Dr. Margaret Hamburg told the press.  I agree.  Historically, test kits and systems sold to hospitals, labs, physicians and the public have been regulated but if a test is developed by a laboratory and used there it's not, which doesn't seem to be fair.