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The FDA's role is not limited to accredited-party

selection.  In addition, the Agency retains all

the authority it has under current law to make

final product review decisions . . . there is no

presumption given to the accredited party's recom-

mendation of approvability or classification of a

product.57

Although the proposed legislation would probably result

in wider use of third-party review, it represents, in ef-

fect, outsourcing of an activity currently done by FDA

employees.  More positively, should either of the bills or a

compromise between them become law, the legislation might

embolden legislators to further relax the FDA's grip on the

marketing of devices.

Beyond Reform

Reforms are designed to improve or amend a system that

is not functioning properly, not to replace the system.

Reducing the amount of paperwork that goes along with a

regulation is a reform.  Removing an agency's regulatory

power is a remedy, not a reform.

The overriding problem with proposed FDA reforms is

that they leave the medical device approval system unchanged

in its most important aspect.  The FDA will still hold its

gatekeeper monopoly, constricting the market for safe medi-

cal devices.

Independent Review Panels Are Not Independent

Congress has long favored "independent review panels"

as checks on FDA actions, and there are sixteen standing

scientific/medical review panels under the Medical Device

Committee in the FDA's Office for Device Evaluation.  (Each

of the required quarterly meetings of each of the 16 panels

costs $20,000.)58 In addition to subject matter experts, the

medical-device review panels include a consumer's represen-

tative and an industry representative, in nonvoting roles.

The only difference between panel members and regular FDA

personnel is that the members are designated as "special

government employees," meaning that they can work for the

government only a certain number of hours per year.

Many of the problems with FDA review can be traced to

the panels.  This is not an indictment of the panel members,

but of an FDA structure that produces problems that can be