What guidance is available for sponsors to determine how to estimate IVD performance in terms of sensitivity and specificity, how to handle discrepant results, and what to do when a study is performed without a truth standard (“gold standard”) (see the Glossary for definitions)?

FDA has recognized a number of Clinical and Laboratory Standards Institute [(CLSI), formerly National Committee on Clinical Laboratory Standards (NCCLS)] standards related to these issues. A list of these standards, but not the standards themselves, can be found through the database on the CDRH web page http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfStandards/search.cfm National Committee on Clinical Laboratory Standards The agency’s guidance entitled “Statistical Guidance on”.