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ents: the consumers and the manufacturers.  No special

interests or perverse bureaucratic incentives created by

congressional oversight would introduce distortions.

A more basic inquiry is whether the market would demand

that third parties certify effectiveness.  Private certifi-

ers in Europe and much of the rest of the world are required

only to certify that the medical device performs as the

manufacturer intended.  That appears to be sufficient be-

cause the European market is well stocked with safe and

effective devices, as shown by the large numbers of Europe-

an-approved devices that are ultimately approved by the FDA.

Europeans seem to have suffered no systematic health

problems as a result of their certification system, whereas

the benefits of the FDA process are empirically dubious.65

In short, if Congress strips the FDA of the power to re-

strict the actions of other players in the market for medi-

cal information, a requirement that a device perform "as the

manufacturer intended" may be sufficient to produce effec-

tive devices.

Absent any FDA restrictions on the information that

manufacturers can make available, the device manufacturers

would have a major incentive to contract for performance or

effectiveness testing in order to distribute information

with their products.  The effectiveness data must be strong

enough to convince the primary purchasers--the trained

doctors to whom consumers entrust medical decisions or the

pharmacy and drugstore owners who depend on frequent, re-

peated shopping trips by their customers.

Several factors would ensure the accuracy of the manu-

facturer's effectiveness data.  First, there are the motives

of reputation and profit.  Medical devices are purchased to

perform certain tasks and not to be admired on the coffee

table or bookshelf.  Few doctors prescribe, few retailers

stock, and few consumers buy a device that is not effective,

regardless of whether it is safe or not.  Consumers prefer

devices that both do not harm them and that help them.  If

the devices do not help, there is no reason to buy.  Second,

there are sticks to go with the carrot of profit--that is,

tort actions and laws against fraud.  The threat of legal

action for deliberate misrepresentation will buttress the

profit motive and induce manufacturers to market effective

devices.

Removing the FDA's monopoly on information and market

access will also free up another set of market participants

who have their own incentives to qualify the effectiveness

of devices.  Medical professional organizations and research