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FDA addresses fecal occult blood diagnostic devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 17, 2007

Device manufacturers have new guidance for 510k submissions for fecal occult blood (FOB) tests. The guidance issued in August revises previous guidance from 1992 and addresses new developments for FOB tests, informing device manufacturers what the FDA believes they should do before marketing an FOB test.

The guidance addresses only tests used to detect fecal occult blood identified under 21 CFR 864.6550 that detect analytes indicating occult blood in feces. The guidance does not cover devices testing fecal matter for cancer-specific analytes such as tumor antigens.

The FDA cautions device manufacturers to consider conditions that may cause false test results. The guidance

• advises manufacturers to address various analytical performance characteristics of the test such as reproducibility of test results; stability of the device; recommendations for specimen collection, storage and transport; and quality control, including built-in controls
• describes the circumstances under which manufacturers can compare their device to an existing one or conduct clinical studies
• recommends that information included in labeling should address the intended use, directions for use, specimen collection instructions and pre-collection patient instructions, limitations of the test, how to interpret results of testing and how to interpret results of controls

Click here to read the guidance.

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