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tion organizations--in particular, the American Society for

Testing and Materials (ASTM) and the American National

Standards Institute (ANSI), but some are UL standards.  As

an NRTL, UL certifies the safety of products that affect the

occupational safety of employees.  Most of UL's work as an

NRTL involves electrical products, but it also evaluates

fire suppressant and elimination products and liquid petro-

leum gas appliances.25

Even medical equipment carries UL's safety certifica-

tion.  UL tests medical equipment and devices for safety.

Turn over most medical equipment, and there will be the UL

mark.26  To be sold as medical devices, the equipment must

still be approved by the FDA, at enormous cost, but UL has

already certified its safety.

As described below, FDA has initiated a study of alter-

natives to its current regulatory program for medical devic-

es.  UL is one of the certified third parties in the pro-

gram.  That does not mean that the FDA is one of UL's cli-

ents, but it demonstrates that the FDA recognizes UL's

competency.

The Success of Market Certification

In Senate testimony, FDA Commissioner Kessler stated,

"The assurance that FDA is there everyday doing its job is

so fundamental that we have the luxury of taking it for

granted."  One implication of his statement is that the FDA

is necessary for Americans to feel secure about their medi-

cal devices.  Extending that logic, do consumers worry that

their televisions will start fires, or that they will be

injured using their toasters?  Is there a strong popular

demand for the federal government to certify the safety of

consumer products and restrict consumers' access to these

products?

There is no such demand because UL and the other com-

peting certifying organizations already fill the role.  The

market system already produces accurate information about

the quality of consumer products.

The FDA and Medical Devices

Developing a medical device is a lengthy process that

usually goes through three steps after prototypes are first

manufactured: pre-clinical testing on animals, clinical

testing involving human beings, and FDA review for approval.