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come into the market, the testing burden has not become

easier for manufacturers, and consumers are still confident

about the safety of their products.  The adoption of UL's

standards by other certifying agencies exemplifies this.  UL

has been the dominant certifying agency for decades, and it

has already incurred the development cost of these stan-

dards.  Instead of creating new, easier standards, the new

competitors to UL have adopted the efficient, accepted UL

standards and competed on the basis of cost or personal

service.  The integrity of testing standards and certifica-

tion has been upheld.

Appropriately Assign Liability

Some defenses of the current regulatory scheme are

anchored in liability assignment questions.  The argument

goes: The possibility of suffering irreparable damage from a

liability suit involving medical devices can paralyze re-

search, development, marketing, and distribution, and the

FDA's public approval and some degree of immunity from lia-

bility are necessary.  Such scenarios of market paralysis

are offered to justify government regulation as necessary to

appropriately assign or mitigate liability.  In reality,

there is no reason to expect such disasters to occur in

markets for medical devices, any more than in markets for

fire alarms and fire extinguishers.

Concerning manufacturers' refusal to market devices,

Michael Krauss of the George Mason School of Law writes:

Both economic theory and present-day practice sug-

gest that fear of product liability does not stop

manufacturers from producing goods.  Manufacturers

produce motorcycles and ladders despite the ab-

sence of pre-market government approval.  They are

held liable when their product is defectively

designed or manufactured.66

Krauss goes on to say that except for recent cases

involving Class III devices, "FDA approval does not immunize

manufacturers from product liability."67  Moreover, courts

have ruled that FDA approval does not afford protection from

liability.  Therefore, if it is true that fear of liability

judgments would prevent manufacturers from producing devices

if there were no FDA, it should prevent them from doing so

under the current system as well.

Doctors often prescribe FDA-approved therapies for

unapproved uses; such "off-label" uses may account for up to