The Heretic
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- Oct 26, 2002
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Never mind, I found the answer:The Heretic said:It is tempting, but I would think (from my experience in medical devices) that these would be considered a medical device (they do go inside the human body) - so they would be regulated by the FDA. Anybody know one way or the other?
"The Federal Food and Drug Administration was empowered to regulate medical devices in 1938, and it acted vigorously in subsequent decades to remove products from the market that were dangerous or fraudulent, especially after the Medical Device Amendments of 1976 (U.S. Congress 1982:5; FDA May 1999:3).
Vibrators were and are included in its oversight. Ordinary massage vibrators were made Class I devices in 1996, exempting them from premarket notification requirements, although manufacturers must still register with FDA (FDA CDRH Nov. 2000). Before 1996, manufacturers were required to fill out a form that asserted the device's compliance with standards of performance (that is, that they operated as advertised), of electrical and radiation safety, and for branding and labeling (FDA 1995). The FDA has acted against misrepresentation in the advertising and labeling of vibrators, as in cases where they were promoted as effective therapies for polio and arthritis, but not against the devices themselves unless they were an electrical or radiation hazard (Lent 1904:225; U.S. Food and Drug Administration 1963:11-23). The FDA explicitly recognizes massage of the human genitalia as a legitimate therapeutic use of vibrators, including vibrating dildoes for Kegel's exercise. Genital vibrators and vibrating dildoes are Class II products for which manufacturers must complete a performance standards report on FDA form 3500A (FDA 1995; FDA 1998). The devices are listed in the FDA's classification scheme with other technologies that do not require medical supervision or intervention for proper use, including condoms, breast pumps and tampons (FDA 1998). Non-powered dildoes are not regulated at all, and never have been, presumably because there are no electrical, fraud or other consumer hazards associated with them. The FDA's documentation of its policies on these devices and its record of interventions clearly indicate that its only concerns are consumer safety and protection from fraud. There is no indication of any FDA interest in regulating public morality or in restricting consumer access to vibrators or vibrating dildoes through the mediation of prescriptions and/or medical supervision of their use."