FDA ISSUES TWO NEW GUIDANCES

A guidance posted July 26 on the FDA website describes how in vitro diagnostic devices to measure fecal calprotectin in human stool specimens can comply with the special controls requirement for Class II devices.

The document, "Guidance for Industry and FDA Staff -- Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems," can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0275-gdl0001.PDF (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0275-gdl0001.PDF).

Another agency guidance issued July 18 provides updated answers to commonly asked questions about humanitarian use devices and reflects comments the FDA received since issuing an earlier guidance issued in 2001, the agency said. The guidance also clarifies postmarket aspects of Humanitarian Device Exemption regulation.

The document can be viewed at www.fda.gov/cdrh/ode/guidance/1381.pdf (http://www.fda.gov/cdrh/ode/guidance/1381.pdf).