[Congressional Record Volume 143, Number 55 (Thursday, May 1, 1997)]
[Extensions of Remarks]
[Pages E813-E814]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             THE MEDICAL DEVICE REGULATORY FLEXIBILITY ACT

                                 ______
                                 

                            HON. FRED UPTON

                              of michigan

                    in the house of representatives

                         Thursday, May 1, 1997

  Mr. UPTON. Mr. Speaker, during last year's Food and Drug 
Administration [FDA] reform deliberations, two proposals stuck me as 
particularly innovative, commonsense approaches to simplifying the 
regulation of medical devices while fully protecting public health and 
saving agency resources. Today, with my colleagues Representatives 
Eshoo, Greenwood, Towns, and Hall of Texas, I am introducing the 
Medical Device Regulatory Flexibility Act, legislation incorporating 
these proposals, to highlight them and ensure that they are central to 
FDA reform efforts.
  First, this legislation would provide the FDA with greater 
flexibility in classifying devices than current law provides. Under 
current law, lower risk--class I and class II--new devices may go to 
market if the FDA finds that they are ``substantially equivalent'' to 
ready marketed devices. If the new device is unique and

[[Page E814]]

the agency cannot make a determination that it is substantially 
equivalent to a marketed device, current law requires that the device 
be automatically classified as a class III--high risk--device, 
regardless of the actual level of risk posed by the new device. The 
manufacturer must then either complete costly and time-consuming 
clinical studies and submit a new device approval application to the 
agency or must petition the agency for reclassification, which is under 
current law a complex and time-consuming procedure.
  Under my bill, the FDA would be given the statutory flexibility to 
classify a new device based on the risk posed by the device, at the 
request of a manufacturer whose device was determined to be ``not 
substantially equivalent'' to a marketed device. Under the bill, the 
FDA would retain full authority for determining the classification of a 
device. The agency would simply receive a new, risk-based 
classification option. Since class III devices require the most 
intensive review, this proposal should free up agency resources to 
focus on truly high-risk devices.
  Second, this legislation will provide the FDA with a much simpler way 
to recognize device performance standards. Under current law, the FDA 
has the authority to promulgate standards, but the process for doing so 
is tortuous. As a result, the agency has rarely used this authority. 
Under our bill, the agency would retain the authority to promulgate its 
own standards, but could also recognize national and international 
performance standards by identifying and listing the standard in the 
Federal Register. Devise manufacturers would then have the option of 
certifying to the agency that their products met the standard as a way 
of fulfilling all or part of the applicable statutory requirements 
which must be met before devices may be marketed. Devise performance 
standards form the basis for device regulation in the European 
Community. Providing U.S. manufacturers with this option would move 
forward our efforts to harmonize our regulatory systems.
  I would welcome additional cosponsors of this commonsense regulatory 
reform measure. If you would like further information or would like to 
cosponsor this legislation, please call me or Jane Williams, 5-3761, of 
my staff.

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