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tal eye pads and patient examination gloves.  Included in

the higher-risk, Class II devices are "condoms (latex only)"

and "scented or unscented deodorized tampons."44  The prod-

ucts, all subject only to 510(k) notification and not PMAs,

were chosen so that they would require no clinical studies

and little data gathering.

There are two crucial aspects of the pilot program's

operation.  First, the program amounts to no more than out-

sourcing of FDA operations.  The third parties are simply

doing what the FDA would have been doing.  Al Bracey of the

CDRH Division for Small Manufacturer's Assistance suggested

that the program was initiated to save FDA resources and to

expedite approval, not to study the impacts of reforming the

manner in which the FDA reviews devices.45

The second crucial aspect of the program is that the

FDA retains complete control of approval.  The third parties

make recommendations to the FDA, which does what it pleases

with them.  The FDA retains its full monopoly powers.

Bracey believes FDA would make its reasons for disapproval

of a recommendation known, but it is not required.  He also

believes there are no special provisions for manufacturers

whose products are not approved within the pilot program.

Aggrieved manufacturers would have no more recourse than

they currently do, which is limited to attempting to get a

court to rein in the FDA.

The FDA used two principal criteria when it selected

third-party reviewers for participation in the feasibility

study--scientific expertise and avoiding conflicts of inter-

est.  In conversation with the author, Al Bracey stressed

concerns about conflict of interest over technical exper-

tise.  Ten or 11 of the 37 initial applications were not

reviewed, primarily because of the FDA's perception of

conflict of interest.  Seven companies, including UL, made

the FDA's final cut.

As of November 15, 1996, the FDA had received only two

510(k) reviews from third parties.  Bracey agreed that the

program was new, having begun on August 1, 1996, and that

the third parties were, in November, only gearing up to

market their services.  However, in that same length of

time, the FDA had received "approximately 300 510(k)s eligi-

ble for third-party review."46  As a result of the tiny

number of third-party reviews, the FDA called for "comments

on the reasons for the industry's low utilization rate of

the pilot program to date and the steps, if any, that the

FDA should take to address this situation."47  Whatever the

FDA did in response to the information it received has