The Food and Drug Administration proposed classifying a home testing kit for the HIV virus as a Class 3 medical device—in the same class with artificial heart valves and like devices—even though the kit essentially consisted of a cup for holding a urine specimen that would then be sent to a lab. After the classification scheme was shot down by a federal appeals court, the FDA announced its intention to classify as a medical device the envelope used for mailing hair samples to a lab for drug testing. The manufacturer of the envelopes successfully challenged the FDA in court, noting that the agency's rationale had nothing to do with safety and plenty to do with their stated intention to prevent the kind of "family discord" use of a home drug testing kit may entail.

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