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Both Houses of Congress are considering legislation to
reform the FDA, and action is expected because of the pres-
sure generated by the expiration of the Prescription Drug
User Fee Act of 1992 on September 30, 1997. Bills in both
houses provide for third-party review of medical-device
applications, but those bills preserve the FDA's monopoly
control over which devices can be marketed.
Senate
The Senate Committee on Labor and Human Resources ap-
proved S. 830 in June 1997, and the whole Senate is expected
to consider the bill in July. S. 830 directs the secretary
of health and human services (HHS) (hereafter "the secre-
tary") to employ third-party firms to review applications
for the marketing of medical devices.
S. 830 eases restrictions on the use of unapproved
devices when a physician determines that there is no substi-
tute for the device and when the manufacturer of the device
is seeking FDA approval for its marketing. This provision
directly acknowledges the role of the physician in deciding
on the best device for treating the patient. Nevertheless,
it reserves to the FDA the power to take that device out of
the physician's hands should its review convince the agency
(if not the physician) that the device should not be on the
market. In any case, the administration of the provision
promises difficulties.
The legislation directs the secretary to publish stan-
dards for medical devices such that a manufacturer can
obtain access to the market by certifying to the secretary
that a device meets the suitable standard. The secretary is
also directed to accept compliance with any national or
international standard as evidence for the marketability of
a device. The secretary is granted the power to review the
certification statements to ensure that the provisions of
the standard are reached.
The legislation directs the secretary to publish a list
of Class II devices that do not require 510(k) approval
before being marketed. In addition, the secretary is to
respond to requests for adding other devices to that list.
If enacted, this provision will largely restore the 510(k)
process to a notification process as it was originally in-
tended.
Manufacturers whose devices are classified as Class III