Protection for Consumers
Many manufacturers are promoting home tests on the Internet. This could be risky—unless you get savvy about which tests and sites are legitimate and which are bogus. Consumers need to watch out for unapproved home test kits that may be advertised on the web or in magazines.
The FDA, which regulates the home testing market, holds manufacturers of home tests to a rigorous pre-market approval process. For instance, manufacturers who want their tests approved for home use must demonstrate that consumers can get results comparable to those obtained in a professional laboratory.
In addition, manufacturers must pass an intensive review of proposed labeling. A major issue in the review is whether the instructions clearly communicate information to a consumer—and in a way that leads to actions that promote personal or public health and minimize illness.
The following FDA web page has tips and warnings related to buying medical products online: www.fda.gov/oc/buyonline/