Seminars in Oncology
Volume 29, Issue 3 , Pages 294-300 , June 2002

Regulatory issues in tumor marker development

References 

  1. Medical Device Amendments of 1976. Stat. 539. 1976; Pub L. No. 94-295, 90
  2. Cornbleet PJ, Gochman N. Incorrect least-squares regression coefficients in method-comparison analysis. Clin Chem. 1979;25:432–438
  3. Bland JM, Altman DG. Comparing methods of measurement: Why plotting difference against standard method is misleading. Lancet. 1995;346:1085–1087
  4. Evaluation for Precision Performance of Clinical Chemistry Devices: Approved Guideline. 1999; NCCLS document EP5-A
  5. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. 1995; NCCLS document EP9-A
  6. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline. NCCLS document EP10-A. 1998;
  7. Evaluation of Matrix Effects; Approved Guideline. 2001; NCCLS document EP14-A
  8. Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents. Federal Register. 1997;62:62243–62260
  9. FDA Modernization Act. Stat. 2296. 1997; Pub L No. 105-115, 111

 Address reprint requests to Steven Gutman, MD, MBA, Division of Clinical Laboratory Devices, Food and Drug Administration, HFZ-440, 2098 Gaither Rd, Rockville, MD 20850.

☆☆ This is a US government work. There are no restrictions on its use.

PII: S0093-7754(02)50186-X

doi: 10.1053/sonc.2002.33140

Seminars in Oncology
Volume 29, Issue 3 , Pages 294-300 , June 2002