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can protect rights by investigating and prosecuting fraud

when it occurs.  For example, the marketing of a medical

device advertised to consumers as safe and effective but

later shown to be unsafe and ineffective is fraud.  Manufac-

turers of fraudulent medical devices are guilty of crimes

and should be investigated, prosecuted, and punished.

However, fraud cannot be established before a product is

advertised and marketed; it can only be established after a

product has been marketed and evidence exists to prove the

fraudulent act in a court of law.

The concept of justice in America is that one is pre-

sumed innocent until proven guilty.  In the case of medical

devices, this concept of justice implies that the FDA would

have to prove to a court of law that a manufacturer had

engaged in fraud before a product could be legitimately

banned from the market.  Of course, this is not how the

process works under the current system of FDA regulations.

These regulations require manufacturers to "prove their

innocence" by demonstrating that their medical devices are

safe and effective before they market those devices.  This

regulatory process inverts the concept of justice from

"innocent until proven guilty" to "guilty until proven

innocent."

Why the Market Model Will Work for Medical Devices

Third-party certification is an undeniable and unquali-

fied success.  Under the watchful eyes of UL and its compet-

itors, consumers are certain that literally thousands of the

products they use are safe.  Within specified limits, bul-

letproof glass is indeed bulletproof, and smoke detectors go

off in the event of a fire.  Magnetic resonance imaging

(MRI) machines, the Jarvik-7 artificial heart, and cardiac

arrest paddles are different from light bulbs, toasters, and

cordless telephones.  But all are designed to perform spe-

cific functions under specified conditions, and they can be

certified to work as designed without government monopoly of

the certification process.  After all, until about a quarter

century ago, medical devices reached the market without

government approval.  With repeal of the government monopoly

on approval, they can again reach the market as certified

products.  Those that work well will be purchased and used,

and those that do not will languish unsold.  And in cases of

fraud, the manufacturer will be held liable.

Businesses try to attain maximum profits, and harming

customers does not contribute to that goal.  Buying and

selling are rarely single, isolated transactions where the