[Congressional Record Volume 143, Number 69 (Thursday, May 22, 1997)]
[Extensions of Remarks]
[Page E1035]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


[[Page E1035]]


        THE MEDICAL DEVICE REGULATORY MODERNIZATION ACT OF 1997

                                 ______
                                 

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                         Thursday, May 22, 1997

  Ms. ESHOO. Mr. Speaker, I'm pleased to join with my colleague from 
Texas, Mr. Barton, to introduce the Medical Device Regulatory 
Modernization Act of 1997.
  Since coming to Congress over 4 years ago, I have heard a consistent 
message from medical device companies in my district--the Food and Drug 
Administration is not keeping up with innovation. Companies were asking 
for congressional action to help modernize FDA's regulatory process.
  The bipartisan legislation we are introducing today accomplishes that 
goal.
  We've had testimony before the Commerce Committee that the agency 
lacks the resources to keep up with its workload and as a result 
reviews were taking too long.
  The Barton/Eshoo bill frees up FDA resources by allowing for 
independent review for class I and class II devices that are not 
implantable or likely to cause serious harm if they fail. Class I and 
class II devices are relatively less complex, ranging from surgical 
gloves and syringes to MRI machines. By increasing the use of third 
parties for lower risk devices, the agency will be able to focus their 
attention on higher risk, more complicated products that demand greater 
resources and time.
  We were told that a chasm of communication exists between medical 
device companies and the FDA.
  Under our legislation, FDA will be required to meet with applicants 
at their request both during the investigational device exemption phase 
and early on in the product review stage. It is hoped that through this 
increased communication, there will be a greater understanding on the 
part of the applicant as to what the agency will require for approval, 
and a greater understanding by the agency of the technology being 
employed by the applicant.
  We heard that the FDA needs to recognize national and international 
performance standards to cut down on paperwork and redundant reporting 
requirements.
  The bill allows the FDA to recognize national and international 
standards and allows companies to self-certify to these standards. 
There are penalties for the falsification of data and all certification 
information is available at FDA's request.
  Last, companies have raised concerns that in reviewing applications, 
FDA has, in the past, required information from companies that is 
outside the scope of the application.
  The bill makes clear that it is FDA's job to review applications for 
substantial equivalence, for lower risk devices, or safety and 
effectiveness, for higher risk devices. The agency is not charged with 
reviewing relative effectiveness, which should be determined by the 
marketplace, or for reviewing items outside the proposed intent of the 
device; as long as the public health is not at risk.
  These are some of the key provisions of the legislation, but they are 
by no means the only important provisions in this bill. There are 22 
sections to the legislation that address issues including cost market 
surveillance, dispute resolution, humanitarian use of devices, device 
tracking and regulatory harmonization to name a few. It is a 
comprehensive approach to modernizing the way the FDA regulates medical 
devices.
  Representative Barton and I have worked very hard to ensure that this 
bill moves the agency forward. It's a positive blueprint to strengthen 
the FDA's oversight of the public health. I believe it will help the 
agency review products more efficiently and improve communications 
between FDA and industry, brining new products to market and to the 
patients that urgently need them.
  I urge my colleagues to support it.

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