I need a Mad Scientist.

[The Heretic]

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?

Never mind, I found the answer:

"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."

 

[The Heretic]

Pretty much all your vibrators go in, STG, why would this one require regulating that the existing models don't? I can't see any basis for the distinction unless and until you claim medicinal benefit - that's when your FDA sits up and makes you file forms.

Having had direct dealings with the FDA concerning medical devices, I know they have not seen anything on the market that they don't think is a medical device.

Fortunately they recognize that they can't declare anything and everything a medical device, but they do consider vibrators medical devices and do regulate them (see my post above). They chose to ignore non-powered dildos (dildoes?) unless someone is injured or get's sick from one, but believe me, they wouldn't hesitate to step in and shut someone down if they felt the need, or just were feeling cranky.

I have seen them do plenty of dumb and overeaching things - there are some real cowboys in the FDA.

 

[LukkyKnight]

There are some good guys, too. I noted the officialese, and since they already regulate them it stands to reason this new version would be subject to the same laws. The top of the FDA is a political appointee, but he or she seldom has any long-term impact on decisions, merely a tendency to accelerate those which the current administration favors while possibly decelerating others a bit.

 

[The Heretic]

There are some good guys, too.

Well it has been about ten years since I dealt with them, but I doubt they have changed. I once went to conference in DC between a bunch of FDA people and medical device manufacturers to talk about software. There seemed to be two different groups of FDA people; the old school who weren't bad and were reasonable, and the new school people who were all gung-ho and didn't have a clue.

Usually they are okay, but it is best to have your ducks in a row. I wouldn't care to go into business for myself making vibrators - just too much of a hassle dealing with the FDA.

I noted the officialese, and since they already regulate them it stands to reason this new version would be subject to the same laws.

The way you usually get around a lengthy regulatory process is to certify that your device is essentially equivalent to an existing device - at least that is the way it used to be. They changed a bunch of regs back in '92-'93 and now it is much harder to get 510K certification (if anybody ever tells you their product is "approved by the FDA" they are feeding you BS - the FDA never approves anything, they merely certify that it has complies with their regulations, or that you claim it complies).

The top of the FDA is a political appointee, but he or she seldom has any long-term impact on decisions, merely a tendency to accelerate those which the current administration favors while possibly decelerating others a bit.

Umm, as I recall, there has been at least one FDA director that made a number of long term and big changes there - the one that was in when Clinton was president in his first term, I forget his name.