1. 510(k) Submissions for coagulation instruments: guidance for industry and FDA staff,2003
2. Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices,2008
3. ISO 17593; 2007: Clinical laboratory testing and in vitro medical devices — requirements for in vitro monitoring systems for self-testing of oral anticoagulation therapy,2007
4. NCCLS document EP9-A2 (ISBN 1-56238-472-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA,2003
5. NCCLS document EP21-A (ISBN 1-56238-502-X). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA,2003