IVD Study Designs Warrant Consultation With CDRH Staff – Draft Guidance
This article was originally published in The Gray Sheet
Executive Summary
Discrepant resolution alone is an inadequate method for reliably estimating the value of a new diagnostic test in relation to an imperfect standard, an FDA draft guidance states
You may also be interested in...
FDA diagnostics guidance
Agency issues guidance on statistically appropriate practices for reporting qualitative results from studies to assess diagnostic tests. The March 13 document, "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests," makes recommendations for submitting 510(k)s and PMAs for diagnostics. The guidance covers results from different types of studies and describes best practices for data collection and analysis. The guidance also outlines common inappropriate practices, focusing special attention on discrepant resolution and its associated problems. The agency received 11 comments on the 2003 draft version (1"The Gray Sheet" March 17, 2003, p. 11)...
FDA diagnostics guidance
Agency issues guidance on statistically appropriate practices for reporting qualitative results from studies to assess diagnostic tests. The March 13 document, "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests," makes recommendations for submitting 510(k)s and PMAs for diagnostics. The guidance covers results from different types of studies and describes best practices for data collection and analysis. The guidance also outlines common inappropriate practices, focusing special attention on discrepant resolution and its associated problems. The agency received 11 comments on the 2003 draft version (1"The Gray Sheet" March 17, 2003, p. 11)...
GOLD STANDARD FOR NUCLEIC ACID AMPLIFICATION STUDIES SHOULD INCLUDE TESTS OTHER THAN CULTURE, PANEL MEMBERS SUGGEST; FDA POLICY UNDER DEVELOPMENT
Culture testing should be augmented by alternative diagnostic techniques in establishing a gold standard of comparison for nucleic acid-based tests for chlamydia and other diseases, FDA panel members said at a Feb. 11 meeting in Rockville, Maryland. FDA called the joint meeting of its Microbiology, Clinical Chemistry/ Toxicology, Hematology/Pathology and Immunology Panels to gain input on how to evaluate emerging in vitro diagnostic technologies.