PubMed · 15122276
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Aparna Surendran. 2004. US NIH draft guidelines threaten diagnostics sector.. https://doi.org/10.1038/nbt0504-496
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We aimed to describe the availability in the United Kingdom of self-tests that are used to diagnose or screen for conditions without involving a health professional. A systematic Internet search identified 104 unique self-tests related to 24 named conditions including cancers, chronic conditions and infections. These self-tests require various samples including blood obtained using a lancet. The samples are processed at home with results available in minutes or sent to a laboratory for processing with results returned to the individual by e-mail or post. Prices per self-test and condition range from < Pounds 1 to Pounds 76. Self-tests are readily available, and further work is needed to assess their impact.
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The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test Device." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device.