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The Alternative

Is there an alternative to entrusting a monopoly agency

with coercive powers?  Yes.  The alternative requires no

massive expenditures of the public purse to work.  It makes

fullest use of millions of bits of knowledge.  It is based

on individual freedom.  It has a proven record of success.

Privatization of the certification of medical devices

will save lives and alleviate suffering.  It is the effi-

cient, effective alternative to the FDA's current command-

and-control approach to regulation.

Privatization is widely regarded as a positive step for

most areas of government, but many people are reluctant to

privatize an agency concerned with health and safety mat-

ters.  Will the free market work?  It works now and certi-

fies the safety and effectiveness of thousands of products.

It can work for medical devices.

Third-Party Certification

What would happen if the FDA were stripped of its

monopolistic position over market access?  Who would the

public turn to for testing and certification of safety and

effectiveness?  How would the public know medical devices

are safe?  These questions have answers, and the answers

lead to the prospect of an approval process that will be

faster and more responsive to the need for new life-improv-

ing therapies and products.  Not only can consumers get more

speedy and flexible approval of safe devices, but they can

get it without sacrificing quality and effectiveness and at

lower cost.

No one in the market has the capacity to block the sale

of new devices, and no one can prevent consumers and their

medical advisers from making their own decisions about the

medical devices that they use.  Without FDA's monopoly over

market access, the market will be well stocked with safe and

effective devices, and consumers and their advisers--physi-

cians, nurses, pharmacists, physical therapists, and other

health professionals--will have the knowledge to use them

wisely.  Private third parties would certify devices, and

the FDA would retain its role in investigating and prosecut-

ing fraud when it occurs.  This system is preferable to the

current regulatory structure, and it will become a reality

when the FDA's monopoly powers over market access and the

dissemination of information are removed.