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subsumed under two general categories: expertise and incen-

tive for the panels and timeliness of the process.

The FDA is charged with finding the "best and bright-

est" among researchers and medical professionals to staff

its review panels, but reviewers have few incentives to

devote time and energy to review.  Most importantly, panel

members have other full-time occupations.  Although they

should be knowledgeable about the devices under review as

well as about the theories and practices of clinical test-

ing, they are also required to have no conflicts of inter-

est.

The format of the review process builds in delay.  The

members of the review panels are required to have no contact

with any manufacturer; thus, there is no cooperation between

the panel and the manufacturer during product development or

between the review panel and the FDA personnel overseeing

data collection for device review.  This forces the manufac-

turer to do all of its work separately and submit it to a

body that must then take time to review all of the manufac-

turer's material.

Quite apart from expertise and timeliness, the critical

problem in relying more heavily upon the FDA review panels

is not the review panels themselves.  The problem is that

the panels are an extension of the FDA, and an FDA "by any

other name" is an instrument of the FDA's monopoly.  In the

final analysis, the bureaucracy of the FDA, adding its

delays and mistakes, still stands between the manufacturer

that can provide the device and the consumers who need it.

The potential for third-party review lies in the possi-

bility that third parties will conduct the review process in

a fashion different from the FDA's.  Specifically, third-

party approval must be free of the vagueness and arbitrari-

ness that marks the FDA approval process and able to adapt

to changing technological, clinical, and market conditions.

Performance Standards Will Not Eliminate the FDA's Monopoly

Replacing arbitrary command-and-control regulations

with written standards, as required in the pending legisla-

tion, would be a definite improvement over the current

situation.  It would, in fact, offer manufacturers a known

burden of proof.

However, government automatically approaches new regu-

lations from a "one size fits all" mentality.  There is no