The Food and Drug Administration has selling requirements for early pregnancy testing devices.
HCG, human chorionic gonadotropin, is a placental hormone found in serum, plasma and urine. With the appropriate in vitro medical devices, detection of this hormone can indicate whether a woman may be pregnant. Manufacturers can sell hCG in vitro diagnostic devices to physicians' offices and clinical laboratories only after submitting an application that follows the U.S. Food and Drug Administration's requirements.
Data and Statistical Analyses
Manufacturers have to provide different testing data and statistical analyses when submitting an IVD marketing application to the FDA. The FDA requires demonstration of performance characteristics concerning all samples and materials used to detail statistical differences. Another requirement of federal regulation regarding selling of hCG devices is that manufacturers must describe the types of samples used for testing data such as serum and urine from non-pregnant, pregnant and menopausal women.
Manufacturer Statement
The manufacturer can discuss certain aspects of the device regarding the test capabilities. Such capabilities involve the detection of pregnancy based on from when the first missed period happened (no sooner) unless validation is made with the necessary clinical data. The manufacturer may also include references concerning varying levels of hCG that may go undetected during conception, implantation and the first trimester time frame.
Labeling and Limitations
The FDA requires that manufacturers of hCG medical devices provide package insert labels outlining product information. The labels must have concise wording that is easily understandable. Any drawings or illustrations must be clear enough for the average user of the device can interpret. This insert can also describe product limitations. Such information may state the device is not intended for any other use aside from an early detection for pregnancy or positive hCG can still be detected several weeks after an abortion or delivery.
Tags: detection pregnancy, Drug Administration, Food Drug, Food Drug Administration, medical devices, testing data
