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If the currently proposed legislation does not pass, the FDA

can continue to run the pilot program.  After studying the

"feasibility" of such an approach, the agency may conclude

that third-party review is a dismal failure or that it is

irrelevant because most manufacturers chose to certify

through the FDA anyway.  In either case, the FDA would

report to Congress that third-party review is not effective.

As an agency initiative, the FDA can kill the program out-

right and declare it a failure.  It can also drag out the

program for years under continual refunding for more study.

While the program is going on (and it can be prolonged

indefinitely), it can be used to delay consideration of any

legislative proposals for third-party certification.  Legis-

lation, it will be said, should be delayed "pending the

outcome of the pilot program."

A Case for the Market Solution

The theory of political economy tells us that legislat-

ed reform is more costly and harder to achieve than agency

reform, but it is more permanent.  Common sense tells us

that the more power one removes and the more fundamentally

and thoroughly that power is reallocated, the harder and

less likely is the regrowth of the original system.  In the

case of device regulation, the most fundamental and thorough

reallocation of the FDA's powers, and the most permanent

means of altering the monopoly, is legislating the FDA com-

pletely out of its monopoly on certifying medical devices.

That involves dismantling its device certification approval

system and allowing market institutions to certify devices.

The Market Solution: A Question of Rights and Justice

Individuals and groups have the right to trade--that

is, to make binding contracts with one another.  More spe-

cific to the topic of this paper, manufacturers have a right

to market medical devices, and consumers have a right to

purchase those medical devices, provided that both parties

agree to the terms of the contract that binds them.

When the FDA delays or prevents a manufacturer from

marketing a medical device, the FDA has violated that manu-

facturer's right to market that device and the rights of all

consumers who wish to purchase the use of that device.

Governing bodies are established in America to protect

rights, not to violate them.

The FDA or some other enforcement arm of the government