ANSWERS 10/4/1996 FDA STRENGTHENS STANDARDS FOR NEW MEDICAL DEVICES


T96-66                                   Sharon Snider
October 4, 1996                          (301) 443-3285

        FDA STRENGTHENS STANDARDS FOR NEW MEDICAL DEVICES

     The Food and Drug Administration today announced new changes
to manufacturing quality standards for medium and high risk medical
devices to make them safer and more effective, and to align the
United States with emerging regulatory requirements worldwide.
     Manufacturers must now incorporate a set of checks and
balances in their design processes to assure a safe, effective
finished product.  Such pre-production design controls are already
in use in  automotive, aerospace and most Department of Defense
industries. 
     Design controls will save lives and will greatly reduce the
risks from unrecognized design flaws.
     For example, if a manufacturer were planning to design a new
defibrillator for use in hospitals and ambulances to restart the
heart in emergencies, designers would have to consider all aspects
of use in both settings, not just in the hospital.  They would have
to consider storage temperatures in the ambulance, road shock and
vibration, two-way radio interference, electrical noise generated
by the siren and many other factors.  The design would have to be
reviewed throughout development to make sure all requirements were
being met.
                             -More-                  Page 2, T96-66, Standards for New Medical Devices
     Or, if a manufacturer were planning to design a glucose
monitor for use by diabetics to monitor their blood glucose at
home, designers would have to consider special circumstances that
might arise, such as use by diabetics who have diabetic eye
disease, other persons in the home and medical personnel.  They
would also have to consider the effects on the monitor from other
electrical and electronic products in the home such as computers,
televisions, radios, telephones and other medical devices. 
     Under design controls, manufacturers must establish
performance requirements for a device before production, ensure
that device components are compatible with each other, select
adequate packaging materials, and where appropriate do a risk
analysis.
     The new standards, which will be published in the Federal
Register Monday, also include purchasing and manufacturer servicing
controls and clarify requirements of the current Good Manufacturing
Practice (GMP) regulation.
      A Government Accounting Office (GAO) review of medical device
recalls during a six-year period in the 1980s found that about 44
percent of quality problems were attributable to errors or
deficiencies in the device design and could have been prevented
with proper design controls.  Design-related defects have been
found in such critical products as heart valves, catheters,
defibrillators, pacemakers, ventilators, patient chair lifts and
laboratory tests.
                             -More-                 Page 3, T96-66, Standards for New Medical Devices
     The new Quality System regulation will make standards for
American medical devices consistent with quality system
requirements worldwide, thereby meeting an important goal of global
harmonization.  The new standards closely follow the international
standard, ISO 9001, and fulfill a mandate of the Safe Medical
Devices Act of 1990 to harmonize these requirements.
     FDA's move to revise the GMP regulation to include design
controls was endorsed by the GAO in a 1993 report which commended
the agency for taking steps to advance international harmonization
and competition without compromising public health goals.
     The new Quality System regulation incorporate changes
suggested by the medical device industry in response to a proposed
rule published in November 1993 and a working draft published in
July 1995.  The changes, which were endorsed by FDA's GMP Advisory
Committee in September 1995, give manufacturers greater flexibility
in achieving the quality requirements.  The new regulation
describes the objectives of each control tool but allows
manufacturers to develop their own methods for implementing them.
     The regulation does not cover people who service and refurbish
medical devices outside the control of the original manufacturer. 
Servicers and refurbishers will be addressed in a separate
rulemaking, with another opportunity for public comment.
     The Quality System regulation  goes into effect in two stages. 
By June 1, 1997, all elements of the final Quality Systems rule
become effective.  However, to give the industry adequate 
transition time, the design control provisions will not be enforced
until after June 1998--the same time equivalent design controls
become mandatory in Europe. 
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