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accomplished little.  According to a Senate report48 re-

leased in July 1997, fewer than 10 submissions for approval

of medical devices had gone through the third-party (or

"accredited organization") review process in the first 10

months of the program.

Even before the program started, the FDA and the manu-

facturers were well aware of the weak incentives for manu-

facturers to use the program.  The FDA report of a meeting

on June 19, 1996, states

Some industry representatives expressed concern

. . . about the limitations of the pilot program

that may restrict manufacturers' incentive to

participate.  In particular they commented that

including only low- to moderate-risk devices in

the pilot program and limiting third parties' role

to making recommendations rather than final deci-

sions might result in marketing clearances that

are no faster, and perhaps slower, than those made

by FDA alone.49

In response, the FDA set itself a 30-day time frame to re-

spond to all submissions made by third parties, under the

assumption that 30 days plus the private review time will

still be quicker than the FDA's mandated but seldom achieved

90-day review time.50

Despite the limited use of third parties, FDA reported,

Potential third parties expressed strong interest

in the pilot program and indicated that they have

the capability, independence, and controls to con-

duct sound and unbiased reviews.  Most advocated

that the FDA rely on existing accreditation sys-

tems and criteria for potential third parties, and

that the setting of fees should be left to market

forces.51

At the same meeting, some potential third-party review-

ers advocated

Standards-based third party reviews rather than

reviews focused on substantial equivalence; in-

creased harmonization with international stan-

dards; and reliance on existing accreditation

systems and criteria for potential third part-

ies.52

The FDA rejected these ideas.

It said that the program was