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are permitted to petition the secretary for reclassification

of the device as Class I or II.  The secretary has 90 days

to classify a device; currently, on average, the FDA takes

137 days for initial classification.  The pending legisla-

tion would require FDA to respond to a petition for reclas-

sification within 60 days.  Were the secretary to make an

initial classification decision within 90 days and respond

to an appeal for reclassification within 60 days, almost

half a year would lawfully pass before the FDA considered

the device for approval.  In reality, given the FDA record

of meeting deadlines, more time would be expected to pass.

Within one year of its enactment, S. 830 directs the

secretary to accredit individuals and organizations to

review 510(k) applications for devices and to make initial

determination of the classification (Class I, II, or III) of

a device.  The secretary is not directed to accredit indi-

viduals or organizations to review applications for devices

that are "life supporting," "life sustaining," or "intended

for implantation in the human body for a period of over 1

year."  Nor is he directed to accredit third-party review

for Class III devices, but the secretary is granted the

discretion to make such accreditations.

A manufacturer will be able to ask for a third-party

review of its device proposal, and the secretary is to offer

the manufacturer a choice of at least two review organiza-

tions.  Compensation for the review is to be worked out

between the manufacturer and the review organization.

Initially at least, third-party review will be limited

to 510(k) applications; supposedly, all 510(k) reviews will

be completed within 90 days.  The third-party review can

take up to 60 days, and the FDA review of the third party's

recommendation is to be completed in an additional 30 days.

To reach those goals will surely require changes at the FDA

where missed deadlines are common.  Moreover, the imposition

of the deadlines will surely be met with an FDA request for

additional funds for its review activities, even though the

third-party review would greatly reduce its workload.

House

On May 21, 1997, Rep. Joe Barton (R-Tex.) and Rep. Anna

Eshoo (D-Calif.) introduced the Medical Device Regulatory

Modernization Act.  It provides for new rules to govern the

use of "Investigational Devices" that require the secretary

of HHS to define conditions under which devices intended for

human use can be exempted from certain requirements of the