NEWS
11/18/1993

<TITLE>FDA to Strengthen Manufacturing Standards for New Medical Devices</TITLE>
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P93-42                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285



     The Food and Drug Administration today proposed to strengthen
manufacturing standards for new medical devices--a step that could
prevent dozens of deaths and thousands of serious injuries each
year believed caused by poor device design.
     Under the proposal, FDA would add design controls to the Good
Manufacturing Practice regulation.  The current GMP regulation,
issued in 1978,  requires that quality standards be met in the
methods, facilities and controls used in manufacturing, packing,
storing and installing medical devices.
     "The public must have confidence that the medical devices used
to treat them are properly designed," said FDA Commissioner David
A. Kessler, M.D.  "Appropriate design controls during the early
stages of product development will help assure that the finished
device is both safe and effective."
     An FDA review of medical device recalls from October 1983
through September 1989 found that some 44 percent of the quality
problems that led to the recalls were attributable to errors or
deficiencies inherent in the device and that could have been
prevented with proper design controls.
                             -MORE-
ATTENTION TV BROADCASTERS:  Please use open caption for the hearing
impaired.
                                   Page 2, P93-42, Device GMPs
     In addition to heart valves, catheters and defibrillators,
design-related defects have been found in such products as
pacemakers, ventilators, patient chair lifts, laboratory tests and
medical device software.
      In some instances, manufacturers had failed to establish
performance requirements for a device before production, failed to
ensure that device components were compatible with each other,
failed to select adequate packaging materials or failed to do a
hazard analysis.  All of these would be required under design
controls.
     In addition to design controls, the revised GMP regulation
would include new purchasing and servicing controls and clarify
some of the requirements of the current regulation.
     The addition of design controls to the GMP regulation would
make the U.S. standard for medical devices compatible with  that
adopted by the European Community this year.
     The public will have four months to comment on the proposed
regulation, which will be published Nov. 23.  The final regulation
would take effect six months after it is published.
     FDA is one of eight Public Health Service agencies within HHS.
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