Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

[Ecogenetics]. / Okogenetik.

Some examples of ecogenetics--including pharmacogenetics--demonstrate the tremendous variability in genetic constitution within a population as well as between different populations. They are the reason for different atypical responses to xenobiotics, synthetics like drugs, pesticides, insecticides, herbicides, industrial irritation, smog, cigarettes, alcohol, as well as naturally occurring substances like aflatoxines. It is unknown to what extent individuals differ in their susceptibilities and which genetic consequences of exposure of the human population to toxic environmental agents will occur. It is referred to genetic traits causing a predisposition for atypical reactions against chemicals of different structure as well as to the mutagenic and inductive action of such compounds. In this connection, population genetic aspects will be considered. All examples have to be seen in the context of ecogenetics, the genetically determined individual differences in adverse responses to environmental pollutants, and they are of special interest for preventive and industrial medicine.