Clinical Chemistry and Clinical Toxicology Devices Panel

December 7, 1999

Briefing Information

Draft Panel Questions

FDA Regulation of Home-Use In Vitro Diagnostic Devices, Steven Gutman, MD, MBA, and Kimber Richter, MD, CDRH, FDA

*Caillouette, James, C, MD, etc, "Vaginal pH as a marker for bacterial pathogens and menopausal status," Am. J. Obstet. Gynecol., Volume 176, Number 6, pp. 1270-1277.

*Hillier, Sharon L., PhD, etc. "Association Between Bacterial Vaginosis and Preterm Delivery of a Low-Birth-Weight Infant," The New England Journal of Medicine, Dec. 28, 1995, Vol. 333, No. 26, pp. 1737-1742

*Sagawa, Tadashi, etc, "Vaginal and Cervical pH in Bacterial Vaginosis and Cervicitis during Pregnancy," Hokkaido J Med. Sc., 70(6), pp. 839-846, 1995.


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