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Manufacturers' frustration with the slowness of the

medical-device review process was transmitted to the FDA and

to Congress.  The FDA's trial of third-party review is one

response.  It represents no more than a direct payment to

third-party organizations for doing the work that FDA was

supposed to do.  But the FDA retains its monopoly.

Protection from Dangerous Devices

To get straight to the heart of consumers' concerns,

can a company similar to UL protect the public from danger-

ous and ineffective medical devices?  Yes, the public can be

protected to the extent that members of the public desire

protection.

In the absence of the FDA monopoly, devices might be

marketed without third-party certification, but consumers

and their medical advisers or the retailers who have custom-

er contact could decide whether the promise of the device

outweighed its risks, instead of having their decisions

dictated by bureaucrats.  Having more options, rather than

fewer, is normally to the consumer's advantage.  Consumers

averse to risk could limit purchases to certified devices,

and others could, if they chose, purchase uncertified ones,

as is now the case with nonmedical devices.  The lack of

compulsory, monopolized certification is not a problem with

hair dryers and bulletproof glass, failures of which can be

fatal, and there is no reason to expect market certification

of medical devices to be any different.

A key argument for FDA regulation of medical devices is

that consumers do not have information or the specialized

training needed to make good medical decisions.  Market

certification is the answer to this problem; it allows con-

sumers to draw on highly trained and competent assistance.

Consumers would rely heavily on the advice of their physi-

cians as to what they should do, just as they do today.  In

making recommendations, a doctor would rely heavily on the

private certification organizations, knowing that a series

of bad recommendations would greatly damage his or her

practice.

The knowledge accumulated at the FDA would not disap-

pear.  The FDA's competent reviewers would be hired by

third-party organizations; few would hire on in the fast

food industry.  In the absence of FDA-sanctioned gag rules

that limit what manufacturers can tell physicians about

their products, the medical-device companies themselves

would become important sources of information, enabling